Job Title: Senior QA Specialist
Job Number: 24048
Location: Lexington, MA
The individual in this role shall be responsible for review and release of manufacturing/test documentation from manufacturing operations, i.e., review of EBRs, Deviations, CAPAs, etc. Writing and reviewing instructions, as needed, issuing CoAs/CoCs, interacting with CMO/CROs. Performing audit(s) of documentation and CMO/CROs as needed. Be an overall contributor to the QMS.
- Review and address any issues associated with GMP manufacturing of Product.
- Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
- Issue/Review documentation, i.e., Deviations, Investigations, CAPAs, OOS etc, as they occur.
- Assist or conduct training sessions as needed.
- Review and provide input in Quality Agreements, as applicable.
- Assist in internal/external audits, when needed.
- Assume additional responsibilities as assigned.
- Minimum of five (5) years’ experience in GMP regulated industries – preferably Pharma
- BA/BS in Life Sciences or additional relevant work experience.
- Hands on experience in GMP with a start-up pharma company
- Able to work independently and with a multi-disciplinary team.
- Excellent written and verbal communication skills
- Previous experience with Batch/Lot review and disposition in biotech/pharma
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.