About this role
Applies GMP/GLP in all areas of responsibility, as appropriateMonitor 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 findingsReview Instrument qualifications to ensure that work is performed as per the procedureReview and verify invalid data and system suitability failuresReview and close Exceptions under Non-Routine Events, System Suitability Failure, and DeviationsApprove Analytical Method/Protocol/SMIS/Client Parameter per QA procedureTrack and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate reworkSupport other QA compliance-related activities, as neededDiagnose problems, solve simple problems, and suggest solutions to complex problems in the professional areaKeep 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 employeesExercise 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 dataCommunicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns 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 requirementsAuthorization to work in the United States indefinitely without restriction or sponsorshipPreferred Qualifications:
Experience in performing Pharmaceutical analytical testingComputer skills including word processing, spreadsheets, PowerPoint and database is a plusExperience with cGMP and/or FDA regulated environments is a plus Position is full-time, Monday-Friday, 8:00 a.m.-5:00 p.m. with additional hours, as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
We offer excellent full-time benefits including:
Comprehensive medical coverage,Life and disability insurance,401(k) with company match,Paid holidays and vacation, Dental and vision options.
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.