Senior Quality Assurance & Compliance Specialist - CDMO

Posted 27 June 2024
Salary Negotiable
LocationWisconsin
Job type Full Time
Discipline Large MoleculeSmall Molecule
ReferenceBBBH1770_1719500064
Contact NameTiaan Marufu

Job description

​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.