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 precision
- Review/prepare standards and samples for analysis and running a variety of equipment or instrumentation independently
- Troubleshoot and solve instrumental and/or method problems
- Work 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.
Qualifications :
Preferred Qualifications:
- Experience operating GC/MS and/or ICP systems
- Experience with Extractables and Leachables testing
- Experience with ISO10993 and/or ISO18562 testing
- Experience in a cGMP GLP and/or ISO17025 compliant/accredited lab
- Experience with method development and validation
- Experience identifying unknown compounds by mass spec
- Polymeric experience/education
Basic Minimum Qualifications:
- Bachelors degree or higher in Chemistry or related scientific discipline
- At least 1 year of experience operating LCMS
- Authorization to work in the US without sponsorship
Additional Information :
Working schedule will be Mon-Fri 8:00am-5:00pm with occasional overtime as required. Candidates currently living within a commutable distance of Lancaster PA are encouraged to apply.
- 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
To learn more about Eurofins please explore our website .
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time