Extractable and Leachable Scientist
About The Position
Uses GC-MS, LC-MS, and/or ICP-MS to perform extractables and leachables testing in accordance with applicable protocols and SOPs. Generates, compiles, and analyzes complex data. Reviews test results for compliance and reports quality anomalies. Interprets current and historical data and authors technical summaries. Calibrates instruments or verifies calibration before use. Troubleshoots instrumentation and laboratory techniques. Complies with regulatory requirements and current cGxP standards. Participates in required training as both a trainee and trainer. Maintains laboratory supplies, safety, and compliance. Interacts professionally with vendors and cross-functional teams. Assists with method validation, as needed.
Requirements
- Bachelor’s degree in chemistry with minimum 2 years of relevant industry experience OR Master's degree with any relevant industry experience
- Experience in GC-MS, LC-MS, and/or ICP-MS
- Experience operating inside of a GMP lab space
- Strong computer, scientific, and organizational skills
- Experience writing and reviewing detailed technical documents
- Experience with an electronic laboratory information management system
- Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Authorization to work in the United States indefinitely without restriction or sponsorship
Responsibilities
- Uses GC-MS, LC-MS, and/or ICP-MS to perform extractables and leachables testing in accordance with applicable protocols and SOPs.
- Generates, compiles, and analyzes complex data.
- Reviews test results for compliance and reports quality anomalies.
- Interprets current and historical data and authors technical summaries.
- Calibrates instruments or verifies calibration before use.
- Troubleshoots instrumentation and laboratory techniques.
- Complies with regulatory requirements and current cGxP standards.
- Participates in required training as both a trainee and trainer.
- Maintains laboratory supplies, safety, and compliance.
- Interacts professionally with vendors and cross-functional teams.
- Assists with method validation, as needed.
Benefits
- comprehensive medical coverage
- dental
- vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation
- holidays
- Yearly goal-based bonus
- eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
