GLP QA Manager - On-Site Audits & Compliance

Energy Jobline ZR; Pleasanton (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Crystal Bio Solutions in Pleasanton, CA, seeks a hands-on Quality Assurance Manager to independently lead GLP QA activities in a non-management role. This on-site position focuses on audits, master scheduling, client interactions, and FDA GLP inspections, with direct access to senior management.

You will manage deviations, CAPAs, change controls, and QA documentation within an eQMS, ensuring inspection readiness and regulatory compliance for GLP studies and facilities.

Qualifications

• Minimum 5 years of hands-on Quality Assurance experience in a GLP-regulated laboratory.
• Strong practical knowledge of FDA 21 CFR Part 58 and GLP documentation and inspection requirements.
• Experience maintaining GLP Master Schedules and issuing QA documentation.
• Experience hosting client or sponsor audits as an on-site QA contact.
• Experience participating in FDA GLP inspections.

Responsibilities

• Independently conduct GLP QA inspections and audits of study protocols, raw data, final reports, and ensure timely resolution of findings.
• Maintain the GLP Master Schedule and QA tracking records; prepare QA audit reports and Quality Assurance Statements.
• Provide independent quality guidance to study personnel and management; assess compliance with SOPs and regulatory requirements.

Skills

GLP QA

FDA 21 CFR Part 58

Audit host

CAPA & deviations

QA documentation

Education

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences

Tools

eQMS

Job description

Crystal Bio Solutions in Pleasanton, CA, seeks a hands-on Quality Assurance Manager to independently lead GLP QA activities in a non-management role. This on-site position focuses on audits, master scheduling, client interactions, and FDA GLP inspections, with direct access to senior management.

You will manage deviations, CAPAs, change controls, and QA documentation within an eQMS, ensuring inspection readiness and regulatory compliance for GLP studies and facilities.