Responsibilities of the QC Manager:
- Leads a QC program team with shared resources in a matrix style organization; capable of mentoring and managing team members through influence rather than direct authority; ensures delegation to appropriate team members based on expertise.
- Develops, improves, and revise SOPs, test methods, and other GMP documentation as needed.
- Assures compliance of laboratory operations and contributes to laboratory organization including calibration, qualification and requalification of instruments.
- Participate in the qualification of suppliers and resolution of supplier related quality issues.
- Review and approval of Protocols and validation documents to support new products, process changes and qualifications.
- Apply technical expertise to support the development of new formulations or manufacturing processes with appropriate analytical characterization of materials of materials and methods.
- Review and approve all testing results/documentation generated by the QC R&D laboratory.
Requirements of the QC Manager:
- BS in Chemistry or related field.
- Must have 5+ years experience with QC with pharma and/or biotech industry.
- Strong knowledge and understanding of FDA cGMP regulations.
- Experience with and fundamental understanding of FDA regulations and guidance documents.
- Must have direct reports experience.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.