Mantell Associates
Mantell Associates is partnered with a Cell Therapy CDMO who is searching for a Quality Assurance (QA) Specialist to join their team on a 12 month contract, to provide Quality assistance and oversight during manufacturing on the shop floor (upstream and downstream), as required.
QA Specialist – Responsibilities:
- Provides Quality assistance and oversight to operations on the shop floor
- Supports manufacturing operations in real time to identify and address product quality and compliance issues as they arise
- Initiates deviation reports and participates in activities for issue resolution and initiation of CAPAs, as applicable
- Performs daily walkthroughs of manufacturing, storage, and warehouse areas
- Performs and supports changeovers in production area
- Reviews documentation associated with production operations
- Implements and ensures adherence of appropriate regulations and quality standards
- Supports operations to encourage a Quality Culture and ensure a safe working environment
- Maintains appropriate records
- Performs Raw Material inspection and disposition
- Performs routine manufacturing batch production record review in support of product batch release in accordance with specifications and SOPs, as required
- Communicates release status to appropriate personnel
- Writes and reviews Standard Operating Procedures (SOPs) as needed
- Provides training to QA specialists and manufacturing personnel as needed
- Participates in process improvement initiatives
- Participates in audits and other projects as appropriate
- Assists in preparing Annual Product Quality Review as required
- Completes job-related training on-time as required
QA Specialist – Requirements:
- 4+ years of relevant experience in a GMP environment related field and a BS
- 2 + years of relevant experience and a MS
- Prior experience in pharmaceutical industry is preferred
- Biologics manufacturing experience or knowledge a plus
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.