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. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and therapies, and increase laboratory productivity. 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
As a Laboratory Compliance Officer with a strong QA/QC focus, you will be instrumental in ensuring that our laboratory operations adhere to the highest standards of quality, safety, and regulatory compliance. This is a 100% remote position, offering the flexibility to work from anywhere within the United States, while supporting our operations primarily in the Central time zone. You will be responsible for developing, implementing, and monitoring compliance programs related to laboratory testing, data integrity, and quality control processes. Your expertise will be crucial in interpreting complex regulations, guiding teams through audits, and fostering a culture of continuous quality improvement. This role requires a meticulous individual with a deep understanding of GxP regulations (GLP, GCP, GMP), ISO standards, and other relevant industry guidelines, ensuring all laboratory activities meet or exceed regulatory expectations.
Key Responsibilities
- Develop, implement, and maintain quality assurance and quality control programs in accordance with GxP, ISO, and other relevant regulatory standards.
- Conduct internal audits and facilitate external regulatory inspections (e.g., FDA, EMA, CLIA, CAP), ensuring readiness and effective follow-up on findings.
- Review and approve laboratory documentation, including SOPs, validation protocols, test methods, and data reports, for compliance and accuracy.
- Investigate deviations, non-conformances, and out-of-specification results, leading root cause analysis and corrective/preventive action (CAPA) implementation.
- Provide training and guidance to laboratory personnel on quality systems, regulatory requirements, and best practices.
- Monitor changes in regulatory landscapes and update internal policies and procedures accordingly.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to integrate quality and compliance into all laboratory processes.
- Manage document control systems to ensure proper versioning, archiving, and accessibility of critical quality records.
Required Skills
- Proven experience in a QA/QC or compliance role within a regulated laboratory environment (e.g., pharmaceutical, biotech, medical device).
- In-depth knowledge of GxP regulations (GLP, GCP, GMP) and ISO standards (e.g., ISO 17025, ISO 13485).
- Strong understanding of laboratory instrumentation, analytical methods, and data integrity principles.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory requirements clearly.
- Proficiency in conducting internal audits and facilitating external inspections.
- Demonstrated ability to lead CAPA investigations and implement effective solutions.
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmaceutical Sciences).
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific field.
- Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer).
- Experience with LIMS (Laboratory Information Management System) and electronic quality management systems (eQMS).
- Familiarity with clinical laboratory regulations (CLIA, CAP) for applicable roles.
- Experience in a remote working environment with distributed teams.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance plans.
- 401(k) retirement savings plan with company match.
- Paid time off (vacation, sick leave, holidays).
- Employee stock purchase program.
- Tuition reimbursement and professional development opportunities.
- Flexible spending accounts and health savings accounts.
- Employee assistance program and wellness initiatives.
- Remote work flexibility with a supportive virtual team environment.
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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