GLP QA Manager — On-Site Audits & FDA Readiness

CRYSTAL PHARMATECH INC; Pleasanton (CA); Vor Ort; USD 100.000 - 130.000; Vollzeit

Zusammenfassung

Crystal Bio Solutions seeks a hands-on Quality Assurance Manager to independently perform GLP QA activities at our Pleasanton, CA GLP bioanalytical laboratory. The role covers audits, master scheduling, and inspection readiness with senior management access.

This on-site position focuses on QA execution rather than people management. The candidate will host client audits, participate in FDA GLP inspections, and ensure strict adherence to FDA 21 CFR Part 58, SOPs, and CAPA processes while

Qualifikationen

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 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.
• Direct hands-on experience maintaining GLP Master Schedules, auditing study documentation/raw data/final reports, and issuing QA documentation.
• Demonstrated experience hosting client/sponsor audits as an on-site QA contact.
• Direct participation in FDA GLP inspections, including interactions with FDA investigators.
• Experience with deviations, CAPA, change control, SOPs, and quality records.
• Ability to work independently in a lean lab with strong organization and communication.

Aufgaben

• Independently conduct GLP QA inspections and audits of study protocols, critical study phases, raw data, and interim/final reports; document findings and verify timely resolution.
• Maintain the GLP Master Schedule and QA tracking records; prepare and issue QA audit reports and Quality Assurance Statements.
• Assess laboratory compliance with approved protocols, SOPs, FDA 21 CFR Part 58, and other applicable requirements; provide independent quality guidance to study personnel and management.
• Serve as the primary on-site QA host for client audits, including preparation, auditor interactions, document coordination, and follow-up responses.
• Participate in FDA GLP inspections, including inspection readiness activities, investigator interactions, document retrieval, and follow-up on observations.
• Plan and perform internal facility and quality-system inspections; maintain site inspection readiness and track corrective actions.
• Perform hands-on management of deviations, investigations, CAPA, change controls, and related records; evaluate quality risks and CAPA effectiveness.
• Create, review, revise, and control QA procedures, SOPs, audit logs, and quality records; administer workflows in eQMS.

Kenntnisse

GLP QA

Audit Experience

FDA inspections

CAPA

SOPs

Data Integrity

Ausbildung

Bachelor's degree in Biology/ Chemistry/ Pharmaceutical Sciences

Tools

eQMS

Document control systems

Jobbeschreibung

Crystal Bio Solutions seeks a hands-on Quality Assurance Manager to independently perform GLP QA activities at our Pleasanton, CA GLP bioanalytical laboratory. The role covers audits, master scheduling, and inspection readiness with senior management access.

This on-site position focuses on QA execution rather than people management. The candidate will host client audits, participate in FDA GLP inspections, and ensure strict adherence to FDA 21 CFR Part 58, SOPs, and CAPA processes while