Senior Quality Assurance & Compliance Specialist - CDMO

​Mantell Associates is partnered with a global CDMO, who are searching for a Specialist to join their Quality Assurance and Compliance team.

Senior Quality Assurance & Compliance 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

Senior Quality Assurance & Compliance Specialist - Requirements:

• Minimum of Bachelor's degree in Biology of Chemistry (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.