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Senior Director of Quality Control Microbiology
2 weeks ago
We are seeking a highly skilled Laboratory Manager to oversee the day-to-day operations of our Quality Control Microbiology laboratory. The successful candidate will be responsible for ensuring compliance with all regulatory requirements, including cGMPs, FDA, OSHA, and ICH.
">Key Responsibilities- Manage laboratory operations, including employee safety training, technical data, and Personal Protective Equipment (PPE).
- Ensure compliance with all applicable laws, regulatory agency requirements, and corporate policies, standards, and site procedures.
- Organize timely, accurate, and reliable testing of various types of samples, including raw materials, intermediates, and drug products.
- Validate test methods, calibrate equipment, and maintain laboratory data according to regulatory requirements.
- Manage environmental and water quality monitoring and testing.
- Support site goals and projects using technical expertise and special studies.
Preferred qualifications include:
- Bachelor's degree in Microbiology or related field; Master of Science degree preferred.
- Minimum 10 years of experience in the pharmaceutical industry in a technical capacity, laboratory operations, quality, etc.; minimum 5 years of experience in a management role in a laboratory environment.
- Solid experience with method development and validation, stability requirements, and program management.
- Strong laboratory testing skills, including mastery of chromatography, HPLC, GC, and other analytical instrumentation.
We offer a dynamic and inclusive work environment where everyone belongs and is valued for their contributions. Our credo is