About this role
The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds that may pose health risks to the patient. This individual will:
Perform various tasks and analyses of Bio/pharmaceutical ingredients and products with a high degree of accuracy and precisionReview/prepare standards and samples for analysis and running a variety of equipment or instrumentation independentlyTroubleshoot and solve instrumental and/or method problemsWork efficiently, proactively, and productively Ensure that client receives quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations;Evaluate current systems and suggest process improvements when appropriate;Write complete and detailed investigations independently;Support multiple projects simultaneously;Demonstrate leadership qualities and train newer analysts Minimum Qualifications:
Bachelor's degree in chemistry, biology, biochemistry, or related degree concentrationAuthorization to work in the US indefinitely without restriction or sponsorship1 year of GMP laboratory experience1 year of experience with GC/MS in industryPreferred Qualifications:
Experience operating GC/MS and/or ICP systems. Experience with extractables and leachables testingExperience with ISO 10993 and/or ISO 18562 testingExperience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab. Experience with method development and validationExperience identifying unknown compounds by mass spec. Polymeric experience/education Working schedule will be Full-Time, First Shift, M-F 8am-4pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. No relocation assistance will be given. 25% travel may be required. This position is NOT remote.
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.