Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.
Job DescriptionEssential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility, as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Regular attendance and punctuality
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories
Demonstrate understanding of QAU operations and functions
Perform investigation writing and review including thorough root cause analysis and CAPA
Perform internal audits and walk through inspections
Review procedures, methods and protocols
Release analytical reports
Host client audits, appropriately respond to findings and recommendations
Provide information/entries for monthly/quarterly quality reports to management
Conducts all activities in a safe and efficient manner
Communicates effectively with clients and staff members
Take initiative to diagnose problems, solve simple problems, and present suggestions for solutions to complex problems
Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes
Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretation of regulations
Assist and/or prepare and present training programs as needed to satisfy regulatory requirements
Serve as mentor to specialists to successfully complete assignments
Identify and drive process improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity while remaining compliant.
Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents
QualificationsTo perform this job successfully, the individual must be able to independently perform the following requirements below:
Investigation writing and review, including thorough root cause analysis Technical writing and reviewTracking action items and driving to completionAbility to identify trends in recurring eventsWork with the laboratory and support groups to improve quality metrics, and enable CAPA implementationInternal audits support Review/write QAU procedures.Preferred Microbiology backgroundBasic Minimum Qualifications:
Bachelor's degree in Biology, Microbiology or related science fieldStrong computer skills including word processing, spreadsheets, powerpoint and databases is preferredExperience in GMP environment is preferred Additional InformationPosition 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.
What we Offer:
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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.