Title: QA Engineering Specialist

Location: Warren, NJ

Duration: Contract

Full Job Description :

This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Responsibilities:

• QA lead on technology transfer activities (process):

• Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.

• Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.

• Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.

• Support Product/Program Lifecycle Management Activities

• Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.

• Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)

• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.

• Review media simulation activities to ensure successful execution and documentation.

• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.

• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.

• Ensure procedures are adequate to review and confirm appropriateness of data.

• Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

  Requirements:

• B.S. degree required

• Minimum of seven years of experience in the pharmaceutical or related industry.

• Experience in CAR T or Biologics preferred.

• Minimum of six years of experience in the pharmaceutical or related industry.

• Must be knowledgeable on change control process.

• Must be knowledgeable on the process and associated methods for the assigned product.

• Professional certification in Quality Risk Management preferred.

  System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.