Job Title
Quality Control Manager
Job Description
The Quality Control Manager ensures laboratory activities are conducted in compliance with current Good Manufacturing Practices (cGMP), approved methods are followed, and documentation is accurate, complete, and inspection ready.
KEY ACCOUNTABILITIES- Assist with preparation, review, and revision of specifications, analytical methods, and standard operating procedures.
- Maintain raw material, starting material, intermediate, and finished product specifications.
- Support calibration, qualification, and maintenance of QC analytical instrumentation.
- Ensure testing is completed in a timely manner to support manufacturing and development activities.
- Support stability studies, shelf-life evaluations, and analytical reference standard qualification programs.
- Monitor testing activities to ensure compliance with company, client, cGMP, and safety requirements.
- Review laboratory data, notebooks, and test records for accuracy and completeness.
- Investigate out-of-specification (OOS) and laboratory incidents as required.
- Ensure laboratory logbooks and sample storage records are maintained accurately.
- Provide QC review and approval of operational documentation, including SOPs, cleaning procedures, and master batch records.
- Verify alignment between QC specifications and operational procedures and resolve discrepancies.
- Support audit readiness initiatives and regulatory inspections.
- Provide leadership and manage team performance, training, and development activities.
- Assume responsibilities of the Quality Control Manager as required.
EDUCATION / EXPERIENCE- Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline required; Master's degree preferred.
- Five (5) to ten (10) years of Quality Control experience in a pharmaceutical or related regulated environment.
- Thorough knowledge of analytical chemistry, laboratory testing techniques, and analytical instrumentation.
- Strong working knowledge of cGMP regulations and quality systems.
JOB COMPETENCIES- Excellent organizational and planning skills.
- Strong written, verbal, and interpersonal communication abilities.
- High attention to detail and accuracy.
- Strong analytical and problem-solving skills.
- Ability to manage multiple priorities and deadlines.
- Proficiency with Microsoft Office Suite.
- Demonstrated leadership and team management capability.
PHYSICAL DEMANDS & WORK ENVIRONMENT- Frequent lifting, bending, stooping, squatting, pushing, and pulling.
- Extended periods of standing, walking, sitting, and computer work.
- Potential limited exposure to hazardous chemicals.
- Use of required personal protective equipment including safety glasses, laboratory coats, gloves, and specialized laboratory attire.
- Work performed in and around pharmaceutical research and manufacturing environments.
