About the Company
Eurofins Scientific is an international group of laboratories providing testing and support services to the pharmaceutical, food, environmental, agriscience, and consumer product industries. With a network of over 900 laboratories in 50 countries and more than 62,000 staff, Eurofins offers a portfolio of over 200,000 analytical methods. We are dedicated to delivering high-quality, innovative, and reliable services that contribute to global health and safety. Our commitment to scientific excellence and rigorous quality standards makes us a trusted partner worldwide.
Job Description
We are seeking a highly motivated and experienced Laboratory Compliance Officer with a strong QA/QC focus to join our team. This is a 100% remote position, offering the flexibility to work from anywhere within the United States, with a preference for candidates residing in the Eastern Time Zone for optimal team collaboration. The successful candidate will be instrumental in ensuring our laboratory operations adhere to all relevant regulatory requirements, internal quality standards, and industry best practices. This role will involve developing, implementing, and monitoring quality systems, conducting audits, managing documentation, and providing expert guidance on compliance matters to maintain the highest levels of quality and integrity in our scientific output.
Key Responsibilities
- Develop, implement, and maintain quality assurance and quality control programs in accordance with cGMP, GLP, ISO 17025, and other applicable regulatory standards.
- Conduct regular internal and external audits of laboratory facilities, processes, and documentation to ensure compliance with regulatory requirements and internal SOPs.
- Identify compliance gaps, propose corrective actions (CAPA), and monitor their effective implementation and closure.
- Manage and control quality documentation, including SOPs, policies, and records, ensuring they are current, accurate, and accessible.
- Provide training and guidance to laboratory staff on quality systems, regulatory requirements, and best practices.
- Review and approve analytical data, study reports, and validation protocols for accuracy, completeness, and compliance.
- Act as a primary contact during regulatory inspections and client audits, facilitating requests and responses.
- Stay abreast of changes in relevant regulations and industry standards, assessing their impact on laboratory operations and updating quality systems accordingly.
- Support continuous improvement initiatives within the quality system, promoting a culture of quality throughout the organization.
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 cGMP, GLP, and ISO 17025 standards.
- Strong understanding of FDA regulations and guidelines pertinent to laboratory operations.
- Excellent written and verbal communication skills, with the ability to articulate complex compliance concepts clearly.
- Demonstrated ability to conduct effective audits and manage CAPA systems.
- Proficiency in quality management software and remote collaboration tools.
- Exceptional analytical and problem-solving abilities.
- High attention to detail and organizational skills.
Preferred Qualifications
- Bachelor's or Master's degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmaceutical Sciences).
- ASQ Certified Quality Auditor (CQA) or similar certification.
- Experience with LIMS (Laboratory Information Management System) implementation and management.
- Previous experience in a remote compliance role.
- Knowledge of European Pharmacopoeia, USP, and other international standards.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off, including vacation, sick leave, and holidays.
- Flexible 100% remote work environment.
- Opportunities for professional development and continuous learning.
- Employee assistance program.
- Access to cutting-edge scientific resources and a global network of experts.
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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