Senior Quality Control Manager
1 week ago
Senior Quality Control Manager, Microbiology and Sterility Assurance
Position Overview: In this pivotal role, you will oversee the operations of the microbiology quality control laboratory, concentrating on the monitoring of essential environmental parameters, conducting sterility assessments, and performing specialized microbiological analyses. Your duties will encompass ensuring adherence to industry regulations, managing laboratory operations, collaborating with cross-functional teams, and supervising the validation of novel methodologies and equipment. Additionally, you will cultivate relationships with external laboratories and strategize for future laboratory advancements.
Essential Qualifications:
- Bachelor's degree in Biological Sciences or a related discipline.
- Demonstrated experience in managing pharmaceutical laboratory operations and regulatory compliance.
- A minimum of 10 years of experience in regulated laboratory settings or pharmaceutical manufacturing.
- Thorough understanding of industry standards and regulations, including cGMP, FDA, and international guidelines.
Desirable Qualifications:
- Bachelor's degree in Microbiology or a related field.
Key Responsibilities:
- Lead and mentor a team of QC Microbiology professionals, including recruitment, training, and performance evaluation.
- Develop and execute resource plans for personnel, facilities, and equipment to fulfill operational requirements.
- Enhance laboratory compliance, efficiency, and service quality through proactive management and continuous improvement initiatives.
- Collaborate with project teams to provide timely laboratory support and identify future technological and staffing needs.
- Oversee investigations into laboratory and environmental issues, ensuring effective corrective and preventive actions are implemented.
- Assess the impact of microorganisms on processes and the efficacy of contamination control strategies.
- Manage laboratory method development, validation activities, and vendor audits to ensure quality and compliance.
- Review and evaluate new projects to ensure the laboratory is prepared to support future business growth.
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Senior Quality Control Manager
1 week ago
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Michigan, United States EPM Scientific Full timePosition Title: Senior Quality Control Manager, Microbiology and Sterility AssuranceOverview: In this pivotal role, you will be responsible for directing and supervising the activities of the microbiology quality control laboratory. Your focus will be on assessing essential environmental parameters, conducting sterility assessments, and implementing...
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Michigan, United States EPM Scientific Full timePosition Title: Senior Quality Control Manager, Microbiology and Sterility AssuranceOverview: In this pivotal role, you will be responsible for directing and supervising the activities of the microbiology quality control laboratory. Your primary focus will be on assessing critical environmental parameters, conducting sterility assessments, and performing...
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