Sr. QC Chemistry Associate I
About The Position
The Sr. QC Chemistry Associate I performs complex testing, data review and data analysis for in-process, release, and stability assays of proteins, peptides, and small molecules. Operating with minimal supervision, this role serves as a technical contributor and resource within the team, demonstrating a strong understanding of QC chemistry practices, regulatory compliance, and laboratory workflows. The Sr. Associate I independently supports method transfers, qualifications, and troubleshooting efforts, and may assist in mentoring junior staff. This position ensures adherence to GMP/GLP requirements and contributes to ongoing improvements in quality and efficiency.
Requirements
- High School Diploma required.
- Minimum of six (6) years of relevant experience in a GMP-regulated laboratory setting.
- Strong working knowledge of GMP standards, aseptic techniques, and laboratory best practices.
- Demonstrated ability to perform complex analytical testing accurately and reproducibly.
- Proficiency in troubleshooting instrumentation and assay issues.
- Comfortable providing technical guidance and training to junior team members.
- Proficiency in Microsoft Office applications.
- Detail-oriented with strong written and verbal communication skills.
- Able to work independently and collaboratively in a fast-paced environment.
Nice To Haves
- Bachelor’s degree in Life Sciences discipline or equivalent is strongly preferred.
- Experience with LIMS and QMS systems preferred.
Responsibilities
- Independently performs routine and complex analytical testing for in-process, release, stability, and raw material samples, and provides technical guidance to team members as needed.
- Leads troubleshooting efforts for assays and identifies process improvements to optimize testing efficiency and reliability.
- Authors and reviews data packages, ensuring adherence to cGMP, SOPs, and regulatory expectations.
- Writes, revises, and implements test methods, SOPs, and client-specific protocols, contributing to procedural development and standardization.
- Participates in and may lead method qualifications, validations, and transfers, including drafting of technical protocols and reports.
- Mentors and trains junior QC staff on analytical techniques, documentation practices, and laboratory operations.
- Investigates and documents quality events, including deviations and out-of-specification (OOS) results, with a clear understanding of root cause analysis and CAPA.
- Act as a QC representative in cross-functional or client-facing meetings as needed.
- Oversees maintenance and proper use of laboratory equipment and ensures compliance with calibration schedules and procedures.
- Proactively contributes to continuous improvement initiatives and department goals.
- Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- flexible spending account
- 401(k)
- annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
