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 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.
Requirements
- Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration
- Authorization to work in the US indefinitely without restriction or sponsorship
- 2 years 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
- 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
