Senior QC Chemistry Associate I

10h10 hours ago

PCI Pharma Services

San Diego, US · Full-time · $73,080 – $82,200

About this role

The Senior QC Chemistry Associate I performs complex testing, data review, and data analysis for assays of proteins, peptides, and small molecules. Operating with minimal supervision, the role serves as a technical contributor demonstrating strong understanding of QC chemistry practices and regulatory compliance.

Independently performs routine and complex analytical testing for in-process, release, stability, and raw material samples. Demonstrates strong proficiency in compendial and non-compendial methods such as USP Identification, UV-VIS, SoloVPE, viscosity, Karl Fischer, and chromatography including HPLC and cIEF.

Leads troubleshooting efforts for assays and identifies process improvements to optimize testing efficiency. Authors and reviews data packages ensuring adherence to cGMP, SOPs, and regulatory expectations while writing and revising test methods and client-specific protocols.

Participates in method qualifications, validations, and transfers. Mentors junior QC staff on analytical techniques and documentation practices. Proactively contributes to continuous improvement initiatives and oversees laboratory equipment maintenance and calibration compliance.

Requirements

High School Diploma required; Bachelor’s degree in Life Sciences discipline or equivalent strongly preferred.
Minimum of six 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 and experience with LIMS and QMS systems preferred.
Detail-oriented with strong written and verbal communication skills; able to work independently in a fast-paced environment.

Responsibilities

Independently performs routine and complex analytical testing for in-process, release, stability, and raw material samples.
Demonstrates strong proficiency in compendial and non-compendial methods such as USP Identification, AQL inspection, UV-VIS, SoloVPE, viscosity, Karl Fischer, and chromatography.
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.
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 results with root cause analysis and CAPA.