Job Description

Job Title: QA Specialist II

Location: Alameda, CA

Duration: 12 Months

Job Description:

Key Responsibilities:

• Ensure adherence to company SOPs and GMP standards throughout the manufacturing process.
• Conduct quality reviews of batch records, deviations, change controls, CAPAs, and other quality system documentation.
• Participate in internal audits and inspections to assess compliance with GMP and company policies.
• Support investigation and resolution of non-conformances and implement corrective/preventive actions.
• Collaborate with cross-functional teams including Production, Engineering, and Regulatory Affairs to support continuous quality improvements.
• Maintain accurate and organized documentation in compliance with internal procedures and regulatory requirements.

Qualifications:

• Bachelor’s degree in a scientific or technical discipline or 3–7 years of equivalent quality assurance experience in a GMP-regulated environment.
• Solid understanding of GMP and FDA/ISO regulations.

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