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QA Specialist
Job
Hydrogen Group
Costa Mesa, CA (In Person)
Full-Time
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Job Description
🔹
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 🔹
Qualifications:
- Bachelor's degree in a scientific discipline preferred (or equivalent experience)
- 2-4 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 🔹