We are seeking a QA Consultant to join our team in Hopewell, New Jersey. In this role, you will support QA manufacturing activities in the Warehouse, DS/DP production areas, QC Laboratories as well as Facility/Utility areas that support GMP manufacturing.
Responsibilities:
- Review and approve GMP paperwork including logbooks, analytical raw data, Environmental Monitoring reports, and other ancillary documentation that supports GMP Manufacturing
- Maintain and improve QA operational performance
- Create and/or review SOPs needed to support the business
- Support both internal GMP audits and Health Authority audits
- Implement and monitor all Quality Assurance activities in laboratories and facility/utility space to ensure compliance with FDA/EU regulations
- Ensure the QA Compliance of departmental SOPs (writing & revising)
- Awareness of USP/EP, ICH Guidelines, 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
Requirements:
- 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 years (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)
- Demonstrated expertise with ERP systems such as Maximo, Veeva, and SAP
