Mantell Associates
Mantell Associates is partnered with a rapidly growing CDMO organisation, who are searching for a Specialist to join their Quality Assurance team.
Quality Assurance Specialist – Responsibilities:
- Create, review, and approve documents including standard operating procedures
- Work with Manufacturing and Project Engineers to develop inspection and test methods and related acceptance criteria
- Assist with Quality Assurance reviews of processes
- Provide metrics reporting and status updates to Quality management relating to the facility (PD lab, GMP Facility and QC)
- Management of all documents, manual and electronic documents using Master Control
- Provide daily QA support for general operation activities, calibration status and preventive maintenance status of equipment and system in PD and QC laboratory and GMP Facility
- Support continuous improvement and oversight of Quality management System
- Work within a culture of continuous improvement and system efficiencies
Quality Assurance Specialist – Requirements:
- Minimum of Bachelor’s degree in the Life Science industry (or related)
- Experience in a Quality Assurance position within a highly regulated industry
- Relevant GMP experience in a Pharma/Biotech company, working within quality system and regulated GMP environment
- Strong understanding of quality control standards and testing techniques
- Knowledge of cGMP/ICH/FDA/EU regulations and guidance
- Proficient in using Microsoft applications (Microsoft Word, Microsoft Excel, Microsoft PowerPoint)
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.