- Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of GMP and GCP procedures.
- Review documentation including manufacturing batch records, executed Batch Records, certificates of analysis, stability protocols and reports, and specifications.
- Management and Tracking of external Vendor Quality Events & CAPAs
- Coordinate the review, approval, issue and maintenance of QA controlled documents and records including SOPs, Templates, and Technical Reports.
- Process internal deviations, investigations, CAPAs, and change controls.
- Support regulatory inspections and inspection readiness activities for Quality Systems.
- Bachelor's Degree or equivalent combination of education and experience.
- 5+ years of experience in a quality document management, quality assurance, or quality systems in pharmaceutical, bio-pharmaceutical, or medical device field. Strong knowledge of GXP, SOPs and quality system processes.
- Experience in managing both internal and external records, quality-controlled documents, revision workflows and document change control processes. Experience with an electronic document management system is a plus.