Location: Lakewood, NJ
Requires 2 years of experience in all of the following: 1) Working in the software development industry and participating in a te Jam environment; 2) Automation tools such as Selenium Web Driver; 3) Automation testing using Selenium and/or Web Driver with C#; 4) Java or similar; 5) Relational databases like SQL Server or Postgres.
Requires 1 year of experience in all of the following: 6) Testing web services such as RESTful APIs; 7) Testing using tools such as JMeter; 8) Continuous Integration tools like Bamboo; and 9) AWS services like S3, Lambda. 40 hours/week, $77,813 - $104,000 per year. Must also have authority to work permanently in the U. S. Applicants who are interested in this position may
commercial in-process and final product labels for labeling operations. Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. Coordinates with production teams to ensure timely issuance of labels.
Performs training of label control and issuance requirements for internal personnel as needed. Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required. Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned. Provides support during internal
and health authority inspections and audits of facility. Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
Performs supplemental investigations/projects as required by Management. Maintains knowledge of current GMPs and regulatory guidelines. Must Have: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment preferred Some document management experience. Crystal reports and Bar Tender experience preferred. Experience Basic Qualifications: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment. Some document management
experience. Crystal reports and Bar Tender experience preferred.
Strong communication and customer service skills. Strong computer skills with MS Office (e. g. Word, Adobe, Visio and Excel) and with Quality Systems (e. g. Document Management System, Quality Management System). Develop and improve label issuance processes to drive operational efficiency. Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement. Able to prioritize, manage time well, multi-task, and troubleshoot effectively. Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Possess project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of c GMPs and domestic regulatory requirements. Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc. ). Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network. Education: Bachelor's degree or Associate's Degree with 3+ Years of Experience in a c GMP/FDA Regulated Environment Vinay Bhatiya Associate- Recruitment PAY RANGE AND BENEFITS: Pay Range: $33.00 - $36.00 per hour Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & shop coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) Clearly Rated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : / Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-xyz X. Please indicate the specifics of the assistance needed.
Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (Hire Genics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U. S. C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. Thanks, American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.
PDN-9ae3d1a9-7e1d-40ff-a10b-ad8ffa312d87
of design quality plans and procedures for design-build projects of a similar size and scope. This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits.
With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender
gap, and compliance (aka employee rights, safety and support). DUTIES Managing the scope, schedule, budget, safety, and quality of multiple rail transit construction and design-build projects from commencement to completion.
Coordinating and scheduling engineering and inspection services, maintaining client and subcontractor relationships, and generating and maintaining project status reports. Reviewing and commenting on design documents, including performing constructability reviews; reviewing and approving reports and construction-phase documentation to ensure compliance with project specifications, drawings, building codes, and all other related regulations and applicable industry
standards. Overseeing and managing a project team. Interfacing with owner management teams and labor resources, and acting as owners representative in all forums.
Reviewing schedules and estimates for accuracy. Participating in change order negotiations (including assisting in the creation of scopes of work and independent estimates); Coordinating and executing contractor access and protection requests including track outages / GOs, foul time, property access requests, flag protection, and force-account labor (i. e. track, signal, power, and other owner-employed disciplinary labor groups); Chair meetings and lead project presentations as owners-representatives.
Reviewing and commenting on all meeting minutes. Review proposals, invoices, requisitions, and purchase orders for processing. As well as all other related duties as assigned. QUALIFICATIONS Must have a minimum of 10 years of relevant management and project leadership experience managing projects and associated staff; any other suitable combination of education, training, or experience is acceptable. Bachelor's Degree in Engineering, Construction Management, Architecture, or Business Management is required. A Valid PE or RA License is required. CCM Certification is highly preferred. Must have experience with, executing design-build and/or construction projects within an operating rail transit system, including general knowledge of rail transit operations; Must have an understanding of the fundamentals of rail industry codes, standards, and requirements, with the ability to comprehend construction plans and documents; Must have excellent oral and written communication skills; with outstanding interpersonal skills; Must be detail-oriented, with the ability to multi-task in a fast-paced environment; Must be willing to work nights and weekends as needed.
May also require a valid, clean driver's license and personal vehicle to travel to the project site.
Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport. Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-66f6-4e34-bd41-265e96452bb6
to stop work. The CQCM shall have demonstrated experience in construction with at least 10 years of experience in quality control activities, including preparation and implementation of quality plans and procedures for design-build projects of a similar size and scope.
This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits. With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group
of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender gap, and compliance (aka employee rights, safety and support).
Duties: Develop and implement project-specific quality control. Inspect and evaluate the work area by plans, specifications, and contract documents, reporting deficiencies as appropriate and elevating issues as needed to ensure safe work practices and quality Develop, gather, maintain, and/or submit work plans, submittals, reports, etc. Ensure that subcontractors are aware of all project quality control. Plan for and conduct a three-phase inspection program
to include: Preparatory Meetings and Reports; Initial Phase Inspections and Reports; Follow-up Inspections and Reports; and Final Phase Inspections and Lead and document quality control meetings with the project team and/or customers, and provide written minutes.
Provide daily quality control reports to achieve desired quality outcomes promptly by reinforcing activities that are being constructed in conformance with project-specific standards, and constructively confront non-conformance Verify and document that all materials/equipment received for the project are in conformance with the approved submittal, are handled and stored appropriately, and are acceptable for use in the project; check for damaged and defective materials and address Schedule, coordinate, and document all required code and independent inspections.
Clearly document, correct, and re-inspect all non-conformances before covering up work. Review the as-built drawings to ensure that they are current and that deviations from the contract drawings are Review the Job Site Safety Plan, verify that a hazard analysis has been approved before the performance of a specific feature of work during the preparatory phase of control, verify that safety measures are in place during the initial phase of control, and conduct safety inspections during the follow-up phase of control.
Stop work; reject materials and/or equipment; and direct the removal and replacement of any work not in compliance with contract documents, applicable codes, building standards, and/or established principles of construction engineering, or activities that present life-threatening conditions or damage to the site. Communicate and interact as a team member with all trades, manufacturers, suppliers, construction staff, and customer representatives, in a professional Minimum Requirements: Bachelor's degree in construction management, construction science, engineering, or related field from an accredited university preferred.
Minimum of 10 years experience in programs of similar size and scope. Current OSHA 30; First Aid/CPR; and Construction Quality Control Management certifications; or ability to obtain within 30 days of hire Exceptional communication skills (written and verbal); and ability to interact professionally with customers, coworkers, and subcontractors. Exceptional organizational and time management skills Proficient with Microsoft Office (Outlook, Excel, Word, Power Point, etc. ) and Procore.
Experience in performing, monitoring, and reviewing planning and scheduling functions, which include schedule development, control, and analysis, in the field and the home office. Skilled in oral and written communication. Advanced level of knowledge of engineering, procurement, contracts, construction, and startup work processes, as performed by Bechtel. Knowledge of engineering and construction management customarily acquired over time through specialized instruction or practical experience. Demonstrated ability to plan, organize, direct, perform, review, and present scheduled products independently with minimal supervision.
This includes using a high level of professional judgment and knowledge related to technical planning and scheduling skills and engineering design, construction, and procurement practices. Experience on major lump sum projects with a direct-hire construction strategy is preferred. Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport.
Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-460b-4586-8bda-02cbeb6a7b69
kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients.
Essential Functions and Responsibilities Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves
the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Attends project kick-off meetings to understand the scope of the project.
Creates, updates, reviews and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope. Participates in tech transfer activity to ensure adherence to company quality system standards. Proactively identifies risk and prepares mitigation strategies associated with project and client work. Represents QA Client Services during scheduled meetings with client and cross functional
department. Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.
Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables. Draft initial Quality agreement and complete necessary revisions based on client and company requirements. Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate. Provides quality data to Project Manager for the purpose of creating KPI metrics. Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i. e. Share Point). Communicates internally within QA team to provide key updates on project status, timelines, and deliverables. Formulates and prioritizes appropriate responses to client requests or concerns. Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline. Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis.
Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations. Other duties may be assigned Qualifications Bachelor's Degree in Life Sciences Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (Investigation report, CAPA report, SOPs etc. ) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Familiar with FDA, ISO, and other regulatory agency guidelines. Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. Working knowledge and technical understanding of aseptic manufacture of biologics preferred. Experience in both clinical and commercial manufacturing is preferred. Experience participating health authority inspections and/or client audits preferred. Experience in organizing teams for effective and timely completion of projects.
Competencies/Candidate Profile Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect. Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis. Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
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
