About the Company
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $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, improving patient diagnostics and therapies, or increasing laboratory productivity, we are here to support them. Our global team of more than 100,000 colleagues 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.
Job Description
We are seeking a highly motivated and detail-oriented Laboratory Auditor with a strong focus on Quality Control (QC) to join our global quality assurance team. This role is crucial for ensuring the highest standards of quality and compliance across our laboratory operations. The successful candidate will be responsible for conducting internal and external audits of various laboratories, assessing their adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO standards, and internal quality management systems. This position involves significant travel to various sites, for which a travel stipend will be provided. You will play a pivotal role in identifying areas for improvement, recommending corrective actions, and supporting continuous quality enhancement initiatives.
Key Responsibilities
- Plan, conduct, and report internal and external quality system audits (e.g., GMP, GLP, ISO 17025) of laboratories, including contract laboratories and suppliers.
- Evaluate the effectiveness of quality control processes, methods, and data integrity.
- Identify non-conformances, observations, and areas for improvement, documenting findings accurately and thoroughly.
- Work collaboratively with laboratory staff and management to develop effective corrective and preventive action plans (CAPAs).
- Follow up on CAPA implementation and effectiveness to ensure sustained compliance.
- Maintain detailed audit records and contribute to the overall audit schedule and program.
- Provide expert guidance on regulatory requirements and quality standards to internal stakeholders.
- Participate in the development and revision of quality assurance procedures and documentation.
- Travel extensively to various domestic and international laboratory sites as required to perform audit duties.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmaceutical Science).
- Minimum of 3 years of experience in quality assurance, quality control, or laboratory operations within a regulated industry (e.g., pharmaceutical, biotech, medical device).
- Demonstrated experience conducting laboratory audits or participating in audit processes.
- Strong understanding of GMP, GLP, and/or ISO standards (e.g., ISO 9001, ISO 17025).
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in written and verbal communication, with the ability to present complex information clearly.
- Ability to work independently and as part of a team, managing multiple priorities.
- Willingness and ability to travel up to 50% domestically and internationally.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific field.
- Certification as a Quality Auditor (e.g., ASQ Certified Quality Auditor, IRCA Certified Lead Auditor).
- Experience with electronic Quality Management Systems (eQMS).
- Familiarity with data integrity principles and computerized system validation.
- Experience in a multinational organization.
Perks & Benefits
- Comprehensive Medical, Dental, and Vision insurance plans.
- 401(k) with generous company match.
- Paid Time Off and company paid holidays.
- Life Insurance and Disability coverage.
- Employee assistance program.
- Professional development and career growth opportunities.
- Travel stipend provided for all business travel.
- Wellness programs and employee discounts.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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