QUALITY ASSURANCE ASSOCIATE
Duties: The Gene Therapy Program (GTP) and Orphan Disease Center (ODC) are entering a new era of unprecedented opportunity with great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases. Our R&D organization has a translational infrastructure that includes: technology discovery, specialized immunology assays operating under GLP, a Vector Core/Manufacturing unit that conducts GMP comparable work, and a large non-clinical program for animal testing under GLP including large NHP and rodent vivaria.
Our Quality Assurance (QA) department is currently on the hunt for a QA Associate supporting the development, manufacture, and testing of viral vectors for early phase clinical trials.
As a QA Associate, your activities are critical to ensuring compliance with Good Laboratory Practices (GLP). You will be performing audits of translational research labs against written lab protocols and Standard Operating Procedures (SOP); reviewing SOP's and updating formatting to comply with our standards; perform validation, batch record, and final written report reviews; perform facility audits as well as pre-audit inspections; and with input from the Senior Director, use your discretion and independent judgment in providing recommended corrective actions to management and the study directors.
Also, you will be able to provide guidance and training to staff as it relates to GLP and compliance.
Position is contingent on continued funding.
Qualifications: - A Bachelor's degree in life sciences and 5-7 years of experience in a quality assurance role or an equivalent combination of education and experience is required;
- Experience working in GLP/GMP environment and strong knowledge of GLP/GMP's required
- Experience in cell and gene therapy is strongly preferred.
- Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must
- Strong analytical skills and attention to details required
- Must have demonstrated experience meeting critical deadlines.
-Experience with Microsoft word, excel and access required. Proficiency with access databases preferred.
Reference Number: 40-26116
Salary Grade: 028
Employment Type: Exempt
Org: DM-Gene Therapy Program
Job Family: I-Technical/Professional Research