Quality Assurance Specialist
$71,000–$85,000 year
On-siteIrvine, California, United States
Job Summary
Review and approve all batch records, including those for materials management, manufacturing, testing, packaging, labeling, facilities, and equipment. Work directly with clients to obtain approvals and collaborate with cross-functional stakeholders to ensure timely closure of batch-associated deviations. Support materials management by assigning codes, reviewing specifications, and ensuring supplier approvals. Participate in internal and external audits to ensure inspection readiness for GMP compliance. Provide hands-on support for data review of analytical testing summaries and laboratory investigations. Support quality exceptions by reviewing deviations, CAPA, non-conformances, risk assessments, and change management. Comply with all safety regulations and hazards in manufacturing and laboratory areas.
Required Qualifications
- Minimum 5 years of experience in Quality Assurance
- Hands-on experience performing production line clearance, review/approval master and executed production batch records, review/approval of deviations and implementation of corrective and preventive actions
- Working knowledge of applicable CFR, ICH, and GMP regulations
- Ability to apply and enforce GMP compliance to all aspects of the position
- Detailed attention in job performance
- Excellent written and verbal communication
Desired Qualifications
- Bachelor's degree in science-related field is preferred
- Detailed attention in job performance
- Good attitude, work ethic and natural leadership
- Achievement of an advanced degree or certification
- Excellent written and verbal communication
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