Regulatory Compliance Specialist

Company: Eurofins
Location: Lancaster
Posted on: April 25, 2025

Job Description:

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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
• Support other QA compliance-related activities, as needed
• 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
• May serve as technical advisor for analysts with regard to QA/QC of data
• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Qualifications
  
  Basic Minimum Qualifications:
  • Bachelor's degree in ascience-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:
    
    • Experience in performing Pharmaceutical analytical testing
    • Computer skills including word processing, spreadsheets, PowerPoint and database is a plus
    • Experience with cGMP and/or FDA regulated environments is a plus Additional Information
      
      Positions are full-time, working (Monday-Friday 8:00am-5:00pm),overtime as needed. Candidates currentlyliving within commutable distance to Lancaster, PAare 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
        What Happens Next
        
        Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.
        
        Your data
        
        As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
        
        Closing Date
        
        We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
        
        Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.
        
        Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
        
        Eurofins USA BioPharma Services is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
        PandoLogic. Keywords: Regulatory Compliance Specialist, Location: Lancaster, PA - 17604 , PL: 597211097

Keywords: Eurofins, Cherry Hill , Regulatory Compliance Specialist, Other , Lancaster, New Jersey