Location: Franklin Lakes, NJ
Company: Becton Dickinson
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 Supplier Quality Engineer is responsible to define and implement the supplier management activities required to approve suppliers and maintain their approved status throughout the product lifecycle. This is achieved by ensuring the conformance of the supplier to applicable quality specifications
of components, products, materials, or services delivered to BD, in compliance with BD supplier management policies and procedures, as well as applicable standards and regulations.
Responsibilities Support identification of prospective suppliers. Define the optimum supplier approval strategy, and create supplier approval plans. Facilitate, manage, and track supplier progress toward Approved status, supporting both new product development launches and sustaining engineering changes. Conduct supplier quality audits backssments as necessary including for-cause audits, and complete follow-up and closure of any non-conformances. Author, negotiate, and finalize both Quality and Technical Agreements
with suppliers. Review and approve supplier FMEAs, SPC strategies, MSA documentation, control plans and inspection methods as required by the Supplier Approval Plan.
Provide Supplier Quality Assurance support to all existing suppliers and assigned projects (including suppliers for new product development). Collect and archive all relevant Supplier documentation and required statements. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. Manage changes initiated by suppliers while coordinating with the appropriate project teams. Lead problem solving activities with assigned Suppliers related to escalated customer complaints or manufacturing deviations.
Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).
Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. 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 encourage people with the creativity and aim 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 NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) 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. The Senior Supplier Quality Engineer is responsible to define and implement the supplier management activities required to approve suppliers and maintain their approved status throughout the product lifecycle. This is achieved by ensuring the conformance of the supplier to applicable quality specifications of components, products, materials, or services delivered to BD, in compliance with BD supplier management policies and procedures, as well as applicable standards and regulations.
Responsibilities Support identification of prospective suppliers. Define the optimum supplier approval strategy, and create supplier approval plans. Facilitate, manage, and track supplier progress toward Approved status, supporting both new product development launches and sustaining engineering changes. Conduct supplier quality audits backssments as necessary including for-cause audits, and complete follow-up and closure of any non-conformances. Author, negotiate, and finalize both Quality and Technical Agreements with suppliers.
Review and approve supplier FMEAs, SPC strategies, MSA documentation, control plans and inspection methods as required by the Supplier Approval Plan. Provide Supplier Quality Assurance support to all existing suppliers and assigned projects (including suppliers for new product development). Collect and archive all relevant Supplier documentation and required statements. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. Manage changes initiated by suppliers while coordinating with the appropriate project teams. Lead problem solving activities with assigned Suppliers related to escalated customer complaints or manufacturing deviations.
Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).
Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. 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 encourage people with the creativity and aim 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 NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Apply Save Job PDN-9ae7db20-2dba-4c1c-b8ba-a18d92fecad3
to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance.
In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements. 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 creativity 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 entrepreneurial 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. Main Responsibilities: Evaluation of customer requirements to identify applicable quality standards Serve as core team member
Release product during development activities Realization of quality functional reviews Ensure implementation of PS global procedures and standards for QE engineering activities Provide support to internal, regulatory body and customer audits and associated corrective actions.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products Consistent application of technical principles, theories, concepts and quality sciences / tools Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. Contributes to the completion of specific programs and projects Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers Independently determines and develops approach to solution May provide guidance and work direction to other team members Designs and performs development working independently within defined parameters with minimal supervision required Liaise with Manufacturing Plants Provide functional support to cross-functional teams Define product control strategy Lead risk management activities Ensure design control elements are satisfied Ensure/ perform process validation activities Develop/ perform supplier qualification plans have been defined and completed Evaluate test methods used in project activities Develop systems, processes, and procedures related to project quality activities.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share Ensuring the terms on the agreement are met Support customer facing teams by providing technical support from a quality perspective. Share risk mitigation strategies and control plans for the device with the customers as applicable.
Position Requirements: Education: BS degree in Engineering, or other scientific field Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/ medical) Special Skills: Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMPKnowledge of design control principles. Thorough understanding of statistical methods for Quality Assurance Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management. Knowledge and experience in manufacturing, project management and engineering. Good written and oral communication skillinteractioncellent problem solving and analytical skills Must possess excellent oral and written communication skills, and supervisory/leadership capability.
Ability to handle multiple projects simultaneously in an unsupervised environment. 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 encourage people with the creativity and aim 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 NJ - Franklin Lakes Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform will serve as a core team member, and is responsible for combining design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements. 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 creativity 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 entrepreneurial 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. Main Responsibilities: Evaluation of customer requirements to identify applicable quality standards Serve as core team member Release product during development activities Realization of quality functional reviews Ensure implementation of PS global procedures and standards for QE engineering activities Provide support to internal, regulatory body and customer audits and associated corrective actions.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products Consistent application of technical principles, theories, concepts and quality sciences / tools Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
Contributes to the completion of specific programs and projects Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers Independently determines and develops approach to solution May provide guidance and work direction to other team members Designs and performs development working independently within defined parameters with minimal supervision required Liaise with Manufacturing Plants Provide functional support to cross-functional teams Define product control strategy Lead risk management activities Ensure design control elements are satisfied Ensure/ perform process validation activities Develop/ perform supplier qualification plans have been defined and completed Evaluate test methods used in project activities Develop systems, processes, and procedures related to project quality activities.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share Ensuring the terms on the agreement are met Support customer facing teams by providing technical support from a quality perspective.
Share risk mitigation strategies and control plans for the device with the customers as applicable. Position Requirements: Education: BS degree in Engineering, or other scientific field Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/ medical) Special Skills: Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMPKnowledge of design control principles. Thorough understanding of statistical methods for Quality Assurance Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
Knowledge and experience in manufacturing, project management and engineering. Good written and oral communication skillinteractioncellent problem solving and analytical skills Must possess excellent oral and written communication skills, and supervisory/leadership capability. Ability to handle multiple projects simultaneously in an unsupervised environment. 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 encourage people with the creativity and aim 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 NJ - Franklin Lakes Additional Locations Work Shift Apply Save Job PDN-9a068c7f-b5ff-410f-b193-ee372916692b
various quality continuous improvement activities. Duties & responsibilities. Work in concert with QMS Lead to: Develop and maintain quality programs, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Lead audit and inspection preparation, resolution of audit and inspection
findings and liaises with auditing groups and inspectors through all stages of the audits. Prepare reports and/or necessary documentation (ex Corrective Action Reports) and provides to applicable stakeholders, both internal and external.
Ensure the quality assurance programs and policies are maintained and modified regularly. Management and facilitation of quality documentation system. Candidate must be a self starter, proactive and have good communication skills to support interactions occurring before, during and post audits. Requirements: At least 10 years of expereince. Bachelor's Degree in Computer Science, Electrical Engineering or Information Systems or related field. 5 years of
relevant experience may be substituted for the Bachelor's Degree.
Master's Degree or MBA in related field may be substituted for Bachelor's degree and 3 years experience. Ph D in related field may be substituted for Bachelor's degree and 7 years experience" Job Posted by Applicant Pro
by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc.
is part of the Janssen medical Companies. Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance
the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products?
Apply today for this exciting opportunity! The QASF Associate II is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled c GMP cleanroom environment. Key Responsibilities: • Provide Oversight and Support to clean room activities. • Provider QA shop floor support (Grad-B/ISO-7) for extended periods of time. • Work with Process Development team and Operations organization to successfully
transfer process to c GMP facility to manufacture products. • Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor. • Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised. • Real time review of all documentation and reporting in support of process unit operations. • Support material release in SAP for In-house reagents. • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented. • Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. • Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival • Monitor warehouse, manufacturing, and manufacturing support activities for CG MP compliance through spot checks/internal audits. • Other duties will be assigned, as the need arises. • Support the Shop Floor Order review and Closure process for executed batches and In House reagents/intermediates.
• Responsibilities will include but not limited to tasks mentioned above. Education: Minimum of a bachelor's or equivalent University Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field. Required: • Minimum 2 years of relevant work experience. • Quality Assurance experience within medical or a related industry. • Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidelines. • Highly organized, with demonstrated attention to detail and ability to follow the procedures with minimal direction.
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment. • Proficient verbal communication skills, with the ability to optimally summarize and present results. Preferred: • Experience with aseptic processing in ISO 5 clean room. • Knowledge of c GMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. • Good written and verbal communication skills are required. • Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to collaborate well with stakeholders, customers, and peers. • Ability to manage conflict and issues that arise with internal or external customers. • Ability to handle multiple tasks on same time. • Familiarity with SAP, MES (electronic batch records), Track Wise (quality event management), or equivalent systems. Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 7:30 AM - 6:00 PM/2:00PM-12:30 AM (Sunday-Wednesday/ Wednesday - Saturday), and provide occasional support including nights, weekends, or other shifts with little or no prior notice.
This position has an estimated annual salary of 61,000- 110,000. Requiresthe ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc. ) and to document observations during manufacturing. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc. is part of the Janssen medical Companies.
Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational
treatment. In this role, you will be providing quality oversight for daily activities related to the production of cryopreservation of human apheresis and testing of viral vectors in a controlled c GMP environment.
You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products? Apply today for this exciting opportunity! Main Responsibilities will include, but are not limited to: Partner with Operations teams
to support production activities related Advanced Therapy products in a c GMP manufacturing facility.
Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, backssing impact, and providing quality input on implementation plans. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
Participate in continuous improvement activities. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. Other duties may be assigned as necessary. Education: A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred. Skills & Experience: Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or medical industry, is required.
Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidance Ability to be organized and capable of working in a team environment with a positive demeanor. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred: Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred. Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred. Other: Requires ability and flexibility to work 10-hour shifts 2nd shift. Work Tues-Fri 2nd shift (10 hours) one week, Work Wed-Sat 2nd shift (10 hours) other week, and repeat and provide occasional off shift support, as needed. This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
The anticipated base pay range for this position is $60,000 to $96,600 Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #CAR-T
the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n medicals, LLC is part of the Janssen medical Companies. The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories.
The responsibility includes reviewing and approving, of standard operating procedures (SOPs)/ Forms, validation/ qualification/ method transfer protocols/ reports, completed assay data for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products tested in QC labs which includes In Process, Release, Critical Reagents
and Microbiology labs, Monthly Lab audits, initial approval for retest for SST/AAC/ SAC failures. Closure of QIs related to SST/AAC/ SAC. Key Responsibilities: Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with J&J policies, standards, procedures, and Global c GMP.
Work with QC organization to support the successful transfer of QC Lab functions to the Raritan c GMP facility to test products. Review and approve Technical Documents, Investigational Reports, Completed Daily Assay Data, Personnel Gowning and Pipette Qualifications, Data Generated Reports and Co A's as
applicable. Support the release of patient sample materials. Provide Quality feedback to QC Management by performing spot-checks in the QC Laboratories to ensure compliance.
Strive to reduce non-conformances in supported areas by proactively driving compliance. Strengthen QC Culture and recognize patterns/trends in Shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities. Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities. Routinely recognize and resolve quality issues. Seeks management perspective on quality issues.
Act as liaison for the quality team to guide and improve site improvement projects and strategies. Learn and develop within the business as a Subject Matter Expert on quality assurance topics. Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. Education: Minimum of a Bachelor's Degree required; focused degree in Science or Engineering Technologies preferred Experience and Skills: Required: A minimum of 4 years relevant work experience is required. Knowledge of Gx P regulations and FDA/EU guidance related to manufacturing of biomedicals.
Ability to quickly process information and make critical decisions with minimal oversight. Ability to independently be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive approach under some supervision. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to identify/remediate gaps in processes or systems. Experience with cell and/or gene therapy analytical technique (e.
g. flow cytometry, q PCR) Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Ability to work with others in a team environment and strong interpersonal and written/oral communication skills. Preferred: Experienced in c GMP aseptic manufacturing environments, preferably in quality control, quality assurance, manufacturing, compliance, clinical quality, or cell and gene therapy Detailed knowledge and understanding of current Good Manufacturing Practices (c GMP). Knowledge of current Good Tissue Practices (c GTP) related to CAR-T manufacturing or cell processing Detailed knowledge of CAR-T QC test methods and related equipment is helpful.
Proficient in applying process excellence tools and methodologies (Six Sigma), such as MES, SAP, PAS-X or similar. Other: Requires ability and flexibility to work 8-hour shifts between the operational hours of 8:00 AM - 5:00 PM Monday - Friday, and provide occasional support including nights, weekends, or other shifts with little or no prior notice This position is anticipated to have up to 10% travel The salary for this position is anticipated to be between $75,000 - $110,000.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #car-t
