Quality Systems Specialist II - GMP Release & Compliance

Tri-Valley Career Center

Richmond (CA)

On-site

USD 77,600 - 106,700

Full time

14 days+

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Job summary

Bio-Rad Life Science Group in Richmond, CA is seeking a Quality System Specialist II to support product release, deviation management, and QA initiatives. The role collaborates with Manufacturing, reviews batch records, and contributes to change control, audit support, and CAPA activities.

Based in Hercules with commute to the office, you’ll help ensure regulatory compliance and product quality. The ideal candidate has GMP/regulatory knowledge, 4+ years in a regulated setting, strong data

Qualifications

Associate degree or equivalent in Biology, Chemistry, or related field.
4+ years experience in a regulated industry.
Understanding of GMP and regulatory requirements (US FDA, ISO).
Ability to retrieve, organize, and analyze data to inform decisions.
Willingness to learn product, process, and workflows for continuous improvement.

Responsibilities

Timely product releases from manufacturing to distribution.
Escalate issues to the right department for proper resolution.
Correct processing of Quality Notifications (Deviations and Non-conformances).
Support regulatory and customer audits, including inspection preparation and responses.
Rapid containment of product quality issues from manufacturing or customer complaints.