
Quality Systems Specialist
The Quality Systems Specialist will play a key role in supporting various manufacturing activities across several manufacturing locations on the Hercules campus. Activities will include supporting product and process nonconformance and deviation management and product quality holds. Administration of investigation and deviation systems for tracking status, follow-up and liaison with applicable department investigation assignees. Perform activities related to batch record review, product release, assisting with document inquiries, SAP transactions, and posting of CofAs. Review and compile device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements and document deviations as appropriate. Maintain and archive controlled documentation and completed quality records as needed.
3+ years’ experience in a regulated manufacturing industry
Full knowledge of GMP/ISO regulations (ISO 13485, ISO 14971, MDSAP, IVDD, IVDR and FDA 820).
ISO Auditor certification highly desirable.
Risk Management
Project Management Skills
Time Management Skills
SAP ERP skills
Failure investigations & validation
Driven and self-motivated
Adaptability
Problem Solving Skills
Detail Oriented and Organized
Verbal and Written Communication
Multi tasker
According to JobzMall, the average salary range for a Quality Systems Specialist in 875 Alfred Nobel Dr, Hercules, CA 94547, USA is between $50,000 - $100,000 per year. This salary range can vary depending on factors such as experience, qualifications, and the specific company offering the position.
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Bio-Rad is a global leader, with a team of over 7,800 employees and a global network of operations that serves our life science research and clinical diagnostics customers, helping people live longer, healthier lives.

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