An exciting CDMO company is currently seeking to hire a QC Microbiology Lab Manager to join their growing team near León.
Key responsibilities of the QC Lab Manager include:
- Work in accordance to GMP regulations in a laboratory environment
- Team leadership and supervision; direct reporting line to Head of Quality unit
- Administration and control of the department's resources and materials.
- Preparation, review, approval and control of the GMP documentation generated in the microbiological quality control laboratory.
- Maintain updated GMP documentation that applies to the microbiological quality control laboratory.
- Management, investigation and participation in the actions of the quality events detected in the microbiological quality control laboratory: results out of specifications (OOS), out of trend (OOT), deviations, Change Controls (CC) and Preventive Actions and corrections (CAPA), claims, rejections and withdrawals.
- Initial and continuous training of the Microbiological Quality Control Laboratory staff, in the different instrumental techniques and procedures that apply.
- Supervision and maintenance of the organization and cleaning of the laboratory.
- Management of internal and external audits (clients or competent authorities) as well as visits that take place within the Microbiological Quality Control laboratory
Key requirements of the QC Lab Manager include:
- 5+ years' experience in the pharmaceutical/biotech industry with a focus on the Quality Control space
- Deep experience working in a GMP environment
- Good experience leading laboratory teams (10+ FTE)
- Fluent Spanish and English communication skills