Internship - Quality Assurance

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  • Location: Durham, NC

  • Company: Novo Nordisk

Quality Assurance in Durham, NC

POPULAR
Staff Quality Engineer
1
Staff Quality Engineer
Durham, NC
Dec 19, 2023

of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.

Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference

in our success. The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Quality Assurance related R&D activities from research through product launch.

This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.

Provide clarification and guidance to teams on overall quality system with emphasis in design controls.

Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with Quality Engineers to ensure effective verification of design specifications and requirements. Monitors and ensures compliance with company policies and procedures (e. pliance with FDA, BSI, CSA, etc. ). Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation. Active participant in the development of product requirement, product system hazard analysis and design reviews.

Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support and expertise and analytical problem solving for product development and manufacturing Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams What Success Looks Like in This Role: Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Knowledge of product development processes Represents Quality organization on cross-functional product development Core Team(s)Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience Basic Qualifications: Bachelor's degree in Engineering (or relevant STEM field) and minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control Experience with software and hardware development within a regulated environment is preferred.

Thorough understanding of the risk management and quality by design is preferred Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred)Applicants must be authorized to work for ANY employer in the US.

We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.

In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions.

If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference in our success. The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Quality Assurance related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts.

Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with Quality Engineers to ensure effective verification of design specifications and requirements.

Monitors and ensures compliance with company policies and procedures (e. pliance with FDA, BSI, CSA, etc. ). Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation. Active participant in the development of product requirement, product system hazard analysis and design reviews. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support and expertise and analytical problem solving for product development and manufacturing Ensure product technical files and Design History Files are complete and auditable.

Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams What Success Looks Like in This Role: Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Knowledge of product development processes Represents Quality organization on cross-functional product development Core Team(s)Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience Basic Qualifications: Bachelor's degree in Engineering (or relevant STEM field) and minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control Experience with software and hardware development within a regulated environment is preferred.

Thorough understanding of the risk management and quality by design is preferred Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred)Applicants must be authorized to work for ANY employer in the US.

We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.

And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job PDN-9ae1d1d4-be9b-4576-9da5-227b73a266e9

POPULAR
Senior Quality Engineer, Software
1
Senior Quality Engineer, Software
Durham, NC
Dec 19, 2023

of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.

Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference

in our success. We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.

It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The

Senior Software Quality Engineer is a key member of the New Products Development Team and is responsible for QA-related R&D activities from research through product launch.

This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the primary quality representative for design control projects - new product development as well as sustaining efforts. Responsible for review and/or approval of design history file documentation in support of design controls. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.

Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with other Quality Engineers to ensure effective verification of design specifications and requirements. Monitors and ensures compliance with company policies and international standards. Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.

Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work closely with Product Management to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.

What Success Looks Like in This Role: Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Applies intermediate understanding of regulatory requirements (c GMP, FDA, ISO, etc. ) to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods Able to pull reports (queries), interpret trends and make recommendations for improvement to existing processes and tools Uses comprehensive expertise to help improve and streamline the software quality or development process Represents Quality organization on cross-functional product development Core Team(s) Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers Considered expert in critical areas of the system and influences project test solutions Can apply understanding of the inter-workings of the application code under test Participates in design reviews Applies software engineering knowledge to tasking (e.

g. code and detailed design reviews, low-level white box testing, etc. ) Applies knowledge and skills to a wide range of standard and non-standard situations Basic Qualifications: Bachelor's degree in Engineering (or relevant field) and minimum 5 years' experience with emphasis on Software Quality Assurance and Design Control Thorough understanding of the risk management and quality by design Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Experience in software development and experience within a regulated environment is preferred applicants must be authorized to work for ANY employer in the US.

We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be phenomenal, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.

At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference in our success.

We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.

Become a maker of possible with us. The Senior Software Quality Engineer is a key member of the New Products Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. You will be Accountable for the Following: Responsible for being the primary quality representative for design control projects - new product development as well as sustaining efforts. Responsible for review and/or approval of design history file documentation in support of design controls.

Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with other Quality Engineers to ensure effective verification of design specifications and requirements.

Monitors and ensures compliance with company policies and international standards. Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements. Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work closely with Product Management to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete and auditable.

Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams. What Success Looks Like in This Role: Demonstrates intermediate knowledge of quality engineering policies, principles and best practices Applies intermediate understanding of regulatory requirements (c GMP, FDA, ISO, etc. ) to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods Able to pull reports (queries), interpret trends and make recommendations for improvement to existing processes and tools Uses comprehensive expertise to help improve and streamline the software quality or development process Represents Quality organization on cross-functional product development Core Team(s) Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers Considered expert in critical areas of the system and influences project test solutions Can apply understanding of the inter-workings of the application code under test Participates in design reviews Applies software engineering knowledge to tasking (e.

g. code and detailed design reviews, low-level white box testing, etc. ) Applies knowledge and skills to a wide range of standard and non-standard situations Basic Qualifications: Bachelor's degree in Engineering (or relevant field) and minimum 5 years' experience with emphasis on Software Quality Assurance and Design Control Thorough understanding of the risk management and quality by design Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Experience in software development and experience within a regulated environment is preferred applicants must be authorized to work for ANY employer in the US.

We are unable to sponsor or take over sponsorship of employment visa at this time. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.

In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be phenomenal, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN#SWE Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job PDN-9ae1d1d4-f53d-4c3c-acd6-ec24caa1ed10

POPULAR
Software Quality Engineer
1
Software Quality Engineer
Durham, NC
Dec 24, 2023

provide confidence in delivered software. Special attention is placed on documentation as a support tool for scope, test results, and feature acceptance. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world.

Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually

evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Essential activities of this position Run exploratory tests and writes new test plans.

Document features through testplans, manages test cases as a library. Provide new feature feedback to developers and product owners. Contributeto regression test definition andexecution. Advocate for end users. Perform verification and validation of large pools of data. Decode implied requirements. Strong Communication and Collaboration skills, written and verbal. Ability to ensure testing traceability and create test reports. Partner and collaborate

as part of the development team to deliver high-quality software which.Solves a problem Is easy to use Is reliable Qualifications of this position 2-8 years of experience in software testing or relevant work experience.

Tools include: Postman, Azure Dev Ops, BDDUnderstand human interaction with technology. Maintains a Completion-focused attitude and attentive to details. Ability to think in the abstract and see how small details fit into the bigger picture. Bonus Points for Experience in Strong IT skills Java + Selenium Roboticsshop operations or Healthcare Work environment and physical demands of this position The characteristics described below are representative of those encountered while performing the essential functions of this position.

When properly requested and when feasible (without undue hardship to the organization), reasonable accommodations will be made to enable individuals with disabilities to perform essential job functions. Work will primarily be in the office setting with limited opportunities to be exposed to adverse environmental conditions. Work will be primarily working with fingers by picking, pinching, typing and grasping often with repetitive motion. Must have visual acuity for viewing a computer screen, the ability to talk, hear and sit for extended periods of time.

Must be able to carry, lift and push/pull up to 5 pounds frequently and up to 30 pounds occasionally. Additional physical duties may be required as necessary. While COVID-19 precautions are in effect, this role requires use of face masks/face coverings while working in our facilities. Supervisory/Management position No Advancement opportunities: Senior QA Analyst Automation Engineer Product Owner For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required.

Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.

We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary The Parata QA Analyst focuses on verifying the solution provided by Development matches the needs described by Product. This person advocates for the user during design and testing by regularly questioning the purpose and effectiveness of features. Through this frequent inspection and feedback, you will provide confidence in delivered software.

Special attention is placed on documentation as a support tool for scope, test results, and feature acceptance. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Essential activities of this position Run exploratory tests and writes new test plans. Document features through testplans, manages test cases as a library. Provide new feature feedback to developers and product owners. Contributeto regression test definition andexecution. Advocate for end users. Perform verification and validation of large pools of data.

Decode implied requirements. Strong Communication and Collaboration skills, written and verbal. Ability to ensure testing traceability and create test reports. Partner and collaborate as part of the development team to deliver high-quality software which.Solves a problem Is easy to use Is reliable Qualifications of this position 2-8 years of experience in software testing or relevant work experience. Tools include: Postman, Azure Dev Ops, BDDUnderstand human interaction with technology. Maintains a Completion-focused attitude and attentive to details. Ability to think in the abstract and see how small details fit into the bigger picture.

Bonus Points for Experience in Strong IT skills Java + Selenium Roboticsshop operations or Healthcare Work environment and physical demands of this position The characteristics described below are representative of those encountered while performing the essential functions of this position. When properly requested and when feasible (without undue hardship to the organization), reasonable accommodations will be made to enable individuals with disabilities to perform essential job functions. Work will primarily be in the office setting with limited opportunities to be exposed to adverse environmental conditions.

Work will be primarily working with fingers by picking, pinching, typing and grasping often with repetitive motion. Must have visual acuity for viewing a computer screen, the ability to talk, hear and sit for extended periods of time. Must be able to carry, lift and push/pull up to 5 pounds frequently and up to 30 pounds occasionally. Additional physical duties may be required as necessary. While COVID-19 precautions are in effect, this role requires use of face masks/face coverings while working in our facilities.

Supervisory/Management position No Advancement opportunities: Senior QA Analyst Automation Engineer Product Owner For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer.

We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NC - Durham - Roche Drive Additional Locations Work Shift Apply Save Job PDN-9aebe04b-0ac8-4314-bc5b-5fccf5594b52

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Quality Assurance Label Associate/Specialist
1
Quality Assurance Label Associate/Specialist
Durham, NC
Dec 06, 2023

and industry-leading transparency. With control of the entire supply chain, a state-of-the-art extraction campus near North Carolina's Research Triangle, proprietary refinement and conversion methods backed by a growing IP portfolio, and a team of Ph D chemists and seasoned business leaders, OBX is positioned to be the trusted partner for global brands seeking to enter the marketplace.

THE POSITION We are seeking an experienced Quality Assurance Label Associate/ Specialist (dependent upon experience) who will be responsible for managing label control, reconciliation, and issuance programs as part of our expanding Quality Management System (" QMS" ) which includes: industry,

regulatory, and c GMP manufacturing compliance and certification programs; in-house and third party product quality testing throughout the manufacturing process; and comprehensive SOP's and employee compliance training.

The Quality Assurance Label Associate/ Specialist (dependent upon experience) must bring a high level of energy and possess the leadership and flexibility to adapt to the evolving and infant regulatory landscape of the industry. RESPONSIBILITIES Conducts inspections of incoming retail labels Implementation of a label repository and the authority on label version control Maintains physical inventory and updates documentation of the usage of retail labels Ensures the label

storage locations are maintained in a secure fashion Responsible for label issuance to Finished Goods Manufacturing and Label Reconciliation during and post production Conducts obsolete label and other customer branded material destruction and maintains records accordingly Performs verification that the components listed in the Bill of Materials are correct and compatible with each other and the manufacturing equipment Gathers routine samples from manufacturing areas, performs the required analysis, and records and reports data in a timely manner Coordinate with department managers to develop, write, review and approve SOPs for the entire operation, from through finished product shipping and ensure SOPs are compliant across multiple regulatory frameworks.

Ensure finished products meet labeling standards for hemp including compliance with FDA regulations for foods and dietary supplements, ingredients, limitations on health claims, disclaimers and warnings. General oversight of facility recordkeeping, following Good Documentation Practices Other tasks as necessary to meet business needs. EXPERIENCE HS or equivalent required BS or equivalent in the physical sciences preferred Suggest " At least one year minimum required experience in the food, dietary supplement or medical industry Experience in the cannabis industry preferred but not required.

Strong knowledge of c GMP regulations and auditing techniques. Solid understanding of Quality Control and Quality Assurance c GMP requirements in FDA regulated environments preferred. High level of interpersonal skills, strong leadership abilities, organizational and time management skills. Excellent communicator. Ability to work independently and meet deadlines. OTHER DETAILS This is a full-time position based out of Roxboro, NC. Compensation commensurate with experience. Background and reference checks required.

PHYSICAL DEMANDS AND WORKING ENVIRONMENT: Must be able to lift, carry and balance up to 50 pounds While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and completing repetitive motions. Ability to walk and stand for long periods of time (4-6 hours) with frequent kneeling and bending. Working in limited climate-controlled facilities and may experience extreme heat or cold Work with heavy fumes, plants, airborne particles and chemicals Must be comfortable working with and around heavy machinery May experience moderately high noise levels EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Open Book Extracts is proud to be an equal opportunity employer.

We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

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