Eurofins USA BioPharma Services
Location
Lancaster, PA | United States
Job description
Eurofins is the world leader in the bio/pharmaceutical testing market. With over €6.7 billion in annual revenues and 61,000 employees across 900 sites in 61 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the biopharmaceutical, food and environmental industries.
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.
Eurofins BPT is searching for a BioPharma Regional Sales Manager to drive growth in the Southern California Territory.
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
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
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
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
The position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
Eurofins Lancaster Laboratories is an Equal Employment Opportunity and Affirmative Action employer.
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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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