Quality Assurance Specialist
2 weeks ago
We are seeking a highly skilled Quality Assurance Consultant to support our manufacturing activities in Hopewell, New Jersey. In this role, you will be responsible for ensuring the quality and compliance of our products, processes, and systems.
Key Responsibilities:- Review and approve GMP paperwork, including logbooks, analytical raw data, and Environmental Monitoring reports.
- Maintain and improve QA operational performance, ensuring compliance with FDA/EU regulations.
- Create and/or review SOPs needed to support the business, ensuring they are up-to-date and compliant.
- Support both internal GMP audits and Health Authority audits, ensuring our facilities and processes meet regulatory requirements.
- Implement and monitor all Quality Assurance activities in laboratories and facility/utility space, ensuring compliance with current testing and specifications.
- Ensure the QA Compliance of departmental SOPs, including writing and revising as necessary.
- Awareness of USP/EP, ICH Guidelines, and QC methodology updates to ensure compliance with current testing and specifications.
- Ensure appropriate escalation and follow-up for non-conformities within Laboratories and Utility areas, and issuing deviations when appropriate.
- Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry, or related scientific field) or equivalent work experience.
- Required 3+ years (B.S. degree) or 1 year (M.S. degree) of GMP Pharmaceutical experience working in a quality assurance or quality control role in an FDA-regulated company.
- Working knowledge of cGMPs: 21CFR parts 11, 210 & 211, knowledge of 21CFR600 – Biologics desirable.
- Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook) and ERP systems such as Maximo, Veeva, and SAP.
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