A mid-size biotech company is looking for a Quality Assurance Specialist to join their growing team. The client focuses heavily on rare diseases and has an exciting pipeline ranging from phase 1 clinical trials to commercialized products. With multiple candidates in phase 3 and several more in phase 2, their business is in a strong position headed into 2022. You will have the opportunity to cultivate your quality assurance career at a growing sponsor company where quality and continued growth are a key focus.
The Quality Assurance Specialist will be responsible for:
- Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Support development of commercial and clinical GMP systems
- Batch record review
- Change requests
- Deviation & CAPA review
- Lot release
- Work directly with CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure quality oversight of aforementioned operations
- Assist with QA decision, direction, and leadership in assigned interdepartmental meetings.
- Assist with regulatory inspections.
The Quality Assurance Specialist should have the following qualifications:
- Bachelor's in life sciences or business required
- 2-5 years in life sciences industry related experience
- 2+ year of experience with batch record review and lot disposition
- Healthcare (Medical, Dental, Vision)
- Competitive Pay Rate
- 12+ month contract w/ extension and conversion possibilities
If you are interested in the Quality Assurance Specialist role, then please don't wait to apply.