Sr. QC Chemistry Associate I

Summary

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.

Essential Duties and 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.
• Demonstrates strong proficiency in compendial and non-compendial methods such as USP Identification, AQL inspection, UV-VIS, SoloVPE, viscosity, Karl Fischer, and chromatography (e.g., HPLC, cIEF), ensuring accuracy and compliance.
• 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.

Qualifications

• High School Diploma required. Bachelor's degree in Life Sciences discipline or equivalent is strongly preferred.
• 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.
• Experience with LIMS and QMS systems preferred.
• 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.