Quality System Specialist II - Temporary

The Quality System Specialist will play a role in supporting the Northern California quality management Customer Request request Process for Life Science (LSG) and Clinical Diagnostics (CDG) products. Daily activities would include:

• Facilitate the onboarding of Bio-Rad Laboratories as a supplier to key customers.
• Supporting the intake, management, response, and closure of customer quality documentation requests.
• Coordination and completion of supplier survey questionnaires for customers across a variety of business segments.
• Liaison with U.S. and International sales teams to prioritize high priority customer requests.
• Coordination of product certificate of conformance, certificate of origin, declaration of conformity, and other applicable regulatory and statutory documentation requests.

This position is eligible for a hybrid schedule.

How You'll Make An Impact:

• Support creation of key product QMS survey response forms working with cross-functional subject matter experts to identify responses for the most frequently required customer requests.
• Facilitate the review and approval of customer change and/or quality agreements.
• Review, verify, and close tasks in support of product and process change management file activities.
• Support group Marketing groups in drafting customer notifications.
• Review manufacturing process deviations and non-conformances for potential notification of customers per applicable quality agreements.

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 $30.00 to $43.00 per hour 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 physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status 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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