Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Position Summary
In the role of QC Manager (Microbiology) at Thermo Fisher Scientific Inc., you will be responsible for leading all aspects of Quality Control operations. This includes ensuring regulatory compliance, data integrity, and adherence to corporate standards. You will also collaborate with other site functions to provide expertise in biologic microbiology method qualification and validation strategies.
Responsibilities
- Implement and promote the safety message as the top priority for all employees in the organization, and reinforce it across the facility.
- Ensure compliance with Health Authority regulations.
- Collaborate with Sr. Quality Control Manager, Quality Director, and site leadership to improve the Quality Culture.
- Prepare and manage the Quality Control laboratory budget, implementing cost control measures.
- Ensure comprehensive training of personnel in skills, cGMP, and Safety.
- Lead internal audits, regulatory inspections, and customer audits.
- Ensure timely testing, sampling, and release of microbial tests.
- Conduct routine monitoring of classified environments, purified water, process air, and clean utilities.
- Coordinate daily microbiological laboratory activities to align with cGMP and company standards.
- Lead QC groups and support biologics manufacturing, including product testing and system validations.
- Ensure complete and compliant testing to meet production schedules.
- Manage lab documentation, critical reagents, and microbiological cultures.
- Establish and maintain a microbiological laboratory management system.
- Identify and address gaps in compliance with updated regulations.
- Support facility microbial control strategies and coordinate lab investigations and reports.
- Lead laboratory investigations, deviations, and timely closures.
- Support sterility assurance and aseptic process control.
- Report metrics, track schedules, and ensure adherence to timelines.
- Ensure data integrity principles are applied throughout QC processes.
- Hire, develop, and manage professionals within the Quality Control Microbiology group, providing feedback, mentoring, and opportunities for growth.
Minimum Requirements/Qualifications
Education:
- University degree in chemistry, biochemistry, or life sciences, or equivalent experience
Experience:
- 10 years in the pharmaceutical or medical devices industry, Quality Control
- 6 years in a regulated pharmaceutical QC Microbiology laboratory, 4 years of supervisory or management experience
Skills:
- Knowledge of cGMP environment and regulatory expectations
- Technical expertise in QC microbiology and analytical instrumentation
- Strong interpersonal and communication skills in English
- Understanding of applicable regulatory requirements
- Ability to work cross-functionally to meet timelines and objectives
- Experience in Health Agency/internal audits
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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