Entry-level opportunity for those with education/prior experience in pharmaceuticals or biotechnology.
Our client is a leading biopharmaceutical company in Boston, Massachusetts with an opening for a 'Quality Assurane (QA) Operations Specialist'. Please refer to the job description below and apply with your most up-to-date resume if you are interested in the role.
- Review incoming materials against specifications and submit samples to QC Labs (internal and external) for testing
- Review and approval analytical protocols/reports, OOS results, re-test plans, etc., and associated corrective and preventive action plans
- Support non-conformance (OOT/OOS) investigations, CAPAs, risk assessments, change controls associated to in-house testing.
Required Knowledge & Skills
- Strong leadership skills with the ability to thrive in a high throughput environment
- Proven experience in raw material release and vendor qualifications program
- Familiar with Oracle Process manufacturing (OPM) system
- BS degree required, in the biological or chemical sciences preferred.
- Demonstrated strong working knowledge of GMP manufacturing.
- Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
- Experience in leading and supporting investigations and making decisions around issues that arise during data package review.
Job Title: QA Operations Specialist
Location: Boston, MA
Contract Length: 6 Months, potential to extend
Pay rate: $28-32/hr based on experience.