Sr. Quality Specialist

Eurofins•Lancaster, PA

7d•Onsite

About The Position

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. The Group also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 50 countries. 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. 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

Requirements

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
Authorization to work in the United States indefinitely without restriction or sponsorship

Nice To Haves

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

Responsibilities

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