Manager, Quality Assurance in Pleasanton

Energy Jobline ZR; Pleasanton (CA); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GLP QA

FDA 21 CFR Part 58

Audit host

CAPA & deviations

QA documentation

Ausbildung

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences

Tools

eQMS

Jobbeschreibung

Job DescriptionJob DescriptionPosition Summary

Crystal Bio Solutions is seeking a hands-on Quality Assurance Manager to independently perform and manage day-to-day quality assurance activities at our GLP bioanalytical laboratory in Pleasanton, California. The role is responsible for study and facility audits, maintaining the GLP Master Schedule, hosting client audits, supporting FDA GLP inspections, and maintaining effective quality systems and inspection readiness. This is an on-site, execution-focused position with direct access to senior management; it does not require managing a team.

Key Responsibilities

GLP QA and Study Oversight

• 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.
• Personally maintain the GLP Master Schedule and related QA tracking records; prepare and issue QA audit reports and Quality Assurance Statements, as applicable.
• 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.

Client Audits, FDA Inspections, and Facility Readiness

• Serve as the primary on-site QA host for client and sponsor audits, including preparation, auditor interactions, document coordination, and follow-up responses.
• Participate directly 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 resulting corrective actions.

Quality Systems, Documentation, and Compliance

• Perform hands-on management of deviations, investigations, CAPA, change controls, and associated records; evaluate quality risks and CAPA effectiveness.
• Create, review, revise, and control QA procedures, SOPs, audit logs, and quality records; administer assigned workflows in the electronic quality management system (eQMS).
• Provide QA oversight of laboratory equipment qualification, calibration, maintenance records, computerized system validation documentation, and data integrity practices.
• Coordinate risk-based supplier qualification and oversight activities, including document review, assessments, and supplier audits as applicable.

Training and Collaboration

• Deliver practical GLP training; advise laboratory teams on compliance questions and required corrective actions.
• Prepare regular QA status updates and roll back significant quality issues directly to management.
• Collaborate with laboratory operations and cross-site QA colleagues while retaining accountability for assigned on-site QA activities.

Required Qualifications

• 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, including direct experience performing GLP study and facility QA activities.
• 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 personally hosting client or sponsor audits as an on-site QA contact.
• Direct participation in FDA GLP inspections, including preparation, interactions with FDA investigators, and inspection follow-up.
• Experience working with deviations, CAPA, change control, SOPs, and controlled quality records.
• Ability and willingness to independently execute daily QA work in a lean laboratory environment; strong organization, communication, and judgment skills.

Qualifications

• GLP bioanalytical CRO experience supporting PK/TK, ADA, immunogenicity, biomarkers, or related studies.
• Experience acting as the lead QA representative during an FDA GLP inspection.
• Familiarity with eQMS, computerized laboratory systems, and electronic-records/data-integrity requirements.

Compensation

Actual compensation within the posted range will depend on relevant skills, qualifications, experience, and other job-related factors.

As part of our recruitment process, we may use technology-assisted tools to support application review and improve efficiency. All hiring decisions are made by our team.