Quality System Specialist II - Temporary

Working in Bio-Rad as a Quality Systems Specialist under the Northern California Quality Assurance Operations team, you will support manufacturing activities including investigations of product non- conformance and deviations, blocking of non- conforming material, batch record and CoA review and release. Leveraging your knowledge of Quality principles, you`ll guide the manufacturing partners in correct path for cause investigation and issue resolution. You`ll provide feedback on best practice for documentation and Quality record updates to reinforce Bio-Rad`s Quality Management System.

How You'll Make An Impact:

• Support Bio-Rads top business priority: 3110 BioPharma Demand
• Support batch release for LSG mfg sites
• Support Veeva integration for NorCal (Change Control, Nonconformance Management)
• Verification of Change Control activities
• Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
• Audit preparedness, to reduce audit findings

What You Bring:

• 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/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Working knowledge of device/drug/biotech manufacturing processes.
• Detail-oriented, excellent organization and project management skills and ability to multitask.
• Decision making, time management, organization, communication, leadership, and computer skills.
• Proficient in Microsoft Office, Visio and Excel SalesForce and SAP experience is a plus

Compensation: The estimated hourly range for this position is $34 to $45 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: 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.

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