A long-standing and well-established biopharmaceutical company is looking for a Sr. Clinical Trial QA Specialist to join their Quality team on a 12-month contract. This company leads the development and research for some of the most important drug treatments in oncology, neurology, and rare diseases. They have a robust pipeline of drugs in late-stage clinical trials as well as commercial products being tested for new indications.
The Sr. Clinical Trial QA Specialist will be responsible for:
- Bring on CTM for human clinical trials
- Influence and manage CMO through process set-up
- Approve pre-production records
- Approve post-production records
- Maintain SOP to support CMO operations
- Ensure CMO is compliant with cGMP regulations
The Sr. Clinical Trial QA Specialist should have the following qualifications:
- 3+ years experience in primary and secondary drug packaging
- QA lot disposition, deviations, investigations, training, and auditing experience
- S. in Science, or equivalent
- 3+ years experience in Quality auditing in GMP environment
- Person-in-Plant experience preferred
If you are interested in the Sr. Clinical Trial QA Specialist role, then please don't wait to apply.