Regulatory Compliance Specialist (Senior Quality Specialist)

Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.
Job Description
Job Description

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
• Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
• Review Instrument qualifications to ensure that work is performed as per the procedure
• Review and verify invalid data and system suitability failures
• Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
• Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
• Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
• Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
• Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process

This role may also be directly involved in Client Audits. Clients place great importance on compliance with applicable regulations, data quality, and project requirements and choose to audit our laboratory to confirm that their objectives are being met. Members of the Quality Assurance (QA) Department usually play a key role in these audits. Visits by clients can range anywhere from a tour (to verify facilities and instrumentation) to an intensive inspection of technical operations, procedures, and Regulatory Compliance.
Other Responsibilities May Include:

• Serving as an audit escort
• Answering questions about laboratory and quality systems
• Taking notes throughout an Audit visit to document the scope of the audit and
• items that need to be addressed
• Communicating audit issues to senior management
• Providing formal written responses to client audit reports
• Ensuring follow-up to cited items is performed in a timely manner

Qualifications
Basic Minimum Qualifications:

• Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• Minimum of three years of Pharmaceutical laboratory experience with knowledge of regulatory requirements
• Computer skills including word processing, spreadsheets, PowerPoint and database is a plus
• Experience with cGMP and/or FDA regulated environments is a plus
• Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications:

• Technical writing experience
• Previous experience in client audits as well as internal audits

Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer
All your information will be kept confidential according to EEO guidelines.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.