QA Specialist
Job in
Costa Mesa, Orange County, California, 92626, USA
Listed on 2026-08-04
Listing for:
American Society for Quality
Full Time
position Listed on 2026-08-04
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Production QC/QA
Job Description & How to Apply Below
Responsibilities
- Review executed batch records and supporting documentation for completeness, accuracy, and compliance
- Support product release activities and ensure adherence to cGMP, GDP, and ALCOA+ principles
- Review deviations impacting batch quality and assist with CAPA activities
- Maintain quality documentation and support audit and inspection readiness
- Identify process improvement opportunities and contribute to quality initiatives
- Bachelor's degree in a scientific discipline preferred (or equivalent experience)
- 2+ years of QA experience in a GMP-regulated environment
- Experience reviewing batch records and supporting product release activities
- Working knowledge of FDA, EMA, and cGMP requirements
- Familiarity with quality systems including Deviations, CAPA, Change Control, and Document Control
- Strong attention to detail, organizational skills, and documentation practices
- Experience in pharmaceutical, biotechnology, manufacturing, or other regulated industries
- Strong understanding of quality systems and compliance requirements
- Ability to work independently and manage priorities effectively
- Commitment to quality, integrity, and continuous improvement
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