Senior Quality Specialist

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

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 :

• E xperience 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

Additional Information

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.