GC/MS Scientist- Extractables & Leachables
About The Position
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. They will review/prepare standards and samples for analysis and run a variety of equipment or instrumentation independently. The role involves troubleshooting and solving instrumental and/or method problems, working efficiently, proactively, and productively. Ensuring clients receive quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations is crucial. The individual will evaluate current systems and suggest process improvements when appropriate, write complete and detailed investigations independently, and support multiple projects simultaneously. This role also requires demonstrating leadership qualities and training newer analysts.
Requirements
- GC/MS experience is a MINIMUM REQUIREMENT
- Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration
- Authorization to work in the US indefinitely without restriction or sponsorship
- 1 year of GMP laboratory experience
- 1 year of experience with GC/MS in industry
Nice To Haves
- Experience operating GC/MS and/or ICP systems.
- Experience with extractables and leachables testing
- Experience with ISO 10993 and/or ISO 18562 testing
- Experience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab.
- Experience with method development and validation
- Experience identifying unknown compounds by mass spec.
- Polymeric experience/education
Responsibilities
- 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
Benefits
- comprehensive medical coverage
- dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
