Quality Control Laboratory Manager
$80,000–$80,000 year
On-siteGulfport, Mississippi, United States
Job Summary
Manage laboratory personnel and maintain the quality management system to ensure compliance with 21CFR210/211, cGMP, and regulatory agencies. Audit the Quality Control Laboratory, investigate test problems, and review out-of-specification results to determine root causes and CAPAs. Establish product test methods and specifications, ensure analytical equipment is calibrated, and oversee staff training and discipline. Maintain appropriate inventory and participate in method qualifications and validations. Requires 10+ years of pharmaceutical laboratory management experience, a B.S. in Chemistry or Biology, and full-time onsite work in Gulfport, MS.
Required Qualifications
- 5 years Pharmaceutical Laboratory Manager experience
- 5 years Chemistry/Pharmaceutical experience
- 5 years CGMP experience
- 5 years FDA regulations experience
- B.S. in Chemistry, Biology, or a related discipline
- Experience in computer software, such as Microsoft applications
- Good knowledge and understanding of quality control, SOPs, cGMPs, OSHA, and FDA policies and regulations
- 10+ years of management experience in a pharmaceutical laboratory setting
- Pharmaceutical experience
- Ability to walk, stand, or sit 8 or more hours a day
- Ability to lift heavy items up to 40 lbs. or more
- 100% onsite
- M-F schedule
- Flexible start time between 4am and 11am
- Relocation assistance
- Excellent verbal and written communication skills in English
- Excellent management and teamwork skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Ability to function well in a high-paced and at times stressful environment
- Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company
- Knowledge and control of analytical equipment including calibration and maintenance
- Understanding of quality systems including change control, deviations and CAPAs
- Ability to handle multiple tasks concurrently and complete them in a timely manner
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