Location: Delaware
Reports To: Chief Quality Officer (CQO)
Position Overview
The Quality Control (QC) Manager will oversee GMPLI’s laboratory and testing operations, ensuring that all raw materials, in-process samples, and finished products meet GMP, compendial, and regulatory standards. This role will lead QC teams in supporting the production of GMP-grade water, media, and buffer solutions while maintaining a state of audit readiness.
Key Responsibilities
- Manage daily QC operations, including sampling, testing, and data review.
- Ensure all QC activities comply with USP/EP/JP standards and GMP regulations.
- Oversee method validation, equipment calibration, and laboratory documentation.
- Train and mentor QC staff to ensure technical proficiency and compliance.
- Collaborate with Quality Assurance, Manufacturing, and Supply Chain to resolve quality issues.
- Support investigations, deviations, and CAPAs related to testing activities.
Qualifications
- Bachelor’s degree in Chemistry, Microbiology, or related scientific discipline.
- 5+ years QC experience in pharmaceutical, biotech, or life sciences manufacturing, with at least 2 years in a leadership role.
- Strong understanding of compendial testing requirements and GMP standards.
- Proficiency in laboratory equipment operation and data integrity requirements.
- Strong leadership and organizational skills.
Key Competencies
- Analytical Accuracy
- GMP Compliance
- Team Leadership
- Continuous Improvement
- Problem-Solving