Senior Quality Specialist - Eurofins USA BioPharma Services

Eurofins is the world leader in the bio/pharmaceutical testing market.  With over €5.3 billion in annual revenues and 55,000 employees across 900 sites in 50 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.

The Eurofins BioPharma Product Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world’s largest pharmaceutical and biopharmaceutical companies. The service portfolio supports all stages of the drug development process and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control.

• 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

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 Biopharmaceutical laboratory experience with knowledge of regulatory requirements
• Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications:

• Experience in performing Biopharmaceutical 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
• Experience in quality system responsibilities

The position is full-time, Monday-Friday, 8a.m.-5 p.m., with overtime as needed. Candidates 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.