Bio-Rad is seeking a temporary Quality Systems Specialist to assist the Northern California Quality Assurance Operations team in support of manufacturing activities including, supporting product nonconformance and deviations, product quality holds as well as batch record and general label review and release.
The Quality Systems Specialist will play a key role in supporting manufacturing activities at the Clinical Diagnostic Group site on the Hercules campus. Activities will primarily include supporting product release and process nonconformance and deviation management including follow-up & liaison with applicable department 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.
- Associate degree or equivalent in Biology, Chemistry, or related field.
- 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad with a working knowledge of device/drug/biotech manufacturing processes.
- Detail-oriented and ability to multitask.
- Decision making, time management, organization, communication, leadership, and computer skills.
- Experience with QMS Databases (i.e., EtQ, Trackwise).
- SAP experience a plus
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.