A growing Massachusetts pharmaceutical company is seeking a self-starter with high attention to detail to support their quality and regulatory systems on a full-time permanent, hybrid basis.
Responsibilities:
- Performing QA activities to ensure compliance with internal processes, procedures, US and international regulatory requirements, supporting GMP and GCP procedures.
- Reviewing documentation for the release of combination products, e.g., manufacturing and executed batch records, certificates of analysis, stability protocols, reports, and specifications.
- Managing and tracking external Vendor Quality Events and CAPAs.
- Coordinating the review, approval, issuance, and maintenance of QA controlled documents and records, including SOPs, Templates, and Technical Reports.
- Processing internal deviations, investigations, CAPAs, and change controls.
- Supporting regulatory inspections and participating in inspection readiness activities for Quality Systems.
- Travelling for training and support of external vendors and suppliers.
Requirements:
- Bachelor's Degree or equivalent education and experience.
- Minimum 2 years in quality document management, QA, or quality systems within the pharmaceutical or medical device industry.
- Knowledge of GxP, SOPs, and quality system processes.
- Managed internal and external records, quality-controlled documents, revision workflows, and document change control processes.
- Electronic document management system experience is a plus.
