Quality Assurance Associate
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Job Profile Title
Assistant Manager C
Job Description Summary
The Quality Assurance Associate will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of cell products manufactured at our facility. This position is a crucial component of the success of on-going clinical trials in immunotherapies.
Main duties include:
- Review of in process manufacturing records and product release documentation, verifying that calculations, unique identifiers, and all applicable records adhere to Good Documentation Practices and applicable SOPs.
- Communicate errors and deviations identified during batch record review and follow up to ensure errors are resolved and investigations are initiated and progressing in a timely manner
- Conduct product release functions; therefore, attention to detail and a sense of urgency are crucial. This position will be accountable and responsible of ensuring CVPF products are released according to schedule.
- Anticipate potential roadblocks that may affect product release and alert management, as applicable.
- Other Duties as assigned by management
- Previous experience conducting review of controlled documentation is required. Demonstrated experience in product batch record review according to cGMP guidelines, writing/revising SOPs, working cGMP knowledge, HIPAA requirements.
- 3-5 years of experience working in an FDA/GMP regulated industry, or similar.
- BS in Biology or equivalent scientific discipline; a combination of education and related work experience will be considered
- Strong analytical skills and detail oriented
- Experience meeting critical deadlines; maintaining precision and accuracy while performing under pressure
- Attention to detail is crucial to succeed in this role. The applicant must have an excellent track record or conducting error free review of documentation.
- Weekend work may be required, due to clinical manufacture schedule.
- Previous working experience in a lab setting and familiarity with: ELISAs, flow cytometry, PCR-based assays, sterility testing, etc
- Previous experience in the following: CAPA, Root Cause Analysis, Change Management, Deviations, Inventory Management
- Knowledge in Cell and Gene Therapy and Working knowledge of FACT
This position is contingent upon funding.
Job Location - City, State
Department / School
Perelman School of Medicine
$50,684.00 - $91,232.00
Affirmative Action Statement
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Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.