Job Description
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:
1. Perform tasks and analyses of Bio/pharmaceutical ingredients and products with high accuracy and precision.
2. Review and prepare standards and samples for analysis, operating equipment independently.
3. Troubleshoot and resolve instrumental and method issues.
4. Work efficiently, proactively, and productively.
5. Ensure quality data delivery by reviewing laboratory data for accuracy, clarity, and compliance with GMP and/or GLP regulations.
6. Evaluate current systems and suggest improvements.
7. Write detailed investigations independently.
8. Support multiple projects simultaneously.
9. Demonstrate leadership and train new analysts.
Qualifications include:
* Experience operating GC/MS and/or ICP systems.
* Experience with Extractables and Leachables testing.
* Knowledge of ISO10993 and/or ISO18562 testing.
* Experience in a cGMP, GLP, and/or ISO17025 compliant lab.
* Method development and validation expertise.
* Ability to identify unknown compounds by mass spectrometry.
* Polymeric experience or education, Bachelor's degree or higher in Chemistry or related field.
* At least 1 year of LCMS operation experience.
* Authorization to work in the US without sponsorship.
Company Description
Eurofins Scientific is a global leader in analytical testing services across various industries, ensuring the safety and authenticity of products from food to pharmaceuticals. With a network of over 900 laboratories in 54 countries, Eurofins offers over 200,000 analytical methods to evaluate biological substances and products.
Additional Information
Work schedule: Mon-Fri, 8:00 am - 5:00 pm, with occasional overtime. Candidates within commuting distance of Lancaster, PA are encouraged to apply.
Benefits include comprehensive medical, dental, and vision coverage, life and disability insurance, 401(k) with company match, paid vacation and holidays.
Learn more about Eurofins on our website. Eurofins USA BioPharma Services is an Equal Employment Opportunity employer, supporting Disabled and Veteran applicants.
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