Senior QC Chemistry Associate I: GMP Analytics Lead

PCI Pharma Services; San Diego (CA); On-site; USD 50,000 - 57,000; Full time

Job summary

PCI Pharma Services in San Diego, CA seeks a Sr. QC Chemistry Associate I to perform complex testing, data review, and data analysis for in-process, release, and stability assays of proteins, peptides, and small molecules.

The role operates with minimal supervision and supports method transfers, qualifications, and troubleshooting while mentoring junior staff. The position emphasizes adherence to GMP/GLP requirements, writing and updating SOPs, and contributing to continuous quality improvements

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.

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 [or in accordance with posted schedule].

Skills

GMP compliance

Analytical testing

HPLC analysis

Team collaboration

Education

Bachelor's in Life Sciences

Tools

LIMS

QMS

UV-VIS

Job description

PCI Pharma Services in San Diego, CA seeks a Sr. QC Chemistry Associate I to perform complex testing, data review, and data analysis for in-process, release, and stability assays of proteins, peptides, and small molecules.

The role operates with minimal supervision and supports method transfers, qualifications, and troubleshooting while mentoring junior staff. The position emphasizes adherence to GMP/GLP requirements, writing and updating SOPs, and contributing to continuous quality improvements