Bio-Rad is seeking a Quality System Specialist to join the Northern California Quality Assurance team to support our customer quality documentation request and change control programs.
How You'll Make An Impact:
- The Quality System Specialist will play a role in supporting the Northern California quality management system documentation request and change control programs for Life Science (LSG) and Clinical Diagnostics (CDG) products. Activities will 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.
- Coordination of product certificate of conformance, certificate of origin, declaration of conformity and other applicable regulatory and statutory documentation requests.
- 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.
- Review, verify and close tasks in support of product and process change management file activities.
- Review manufacturing process deviations and non-conformances for potential notification of customers per applicable quality agreements.
- Support other quality and compliance activities as required.
What You Bring:
- High school diploma or equivalent.
- 1+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Basic understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
- Detail-oriented, excellent organization and project management skills and ability to multitask.
- Proficient in Microsoft Office, Visio and Excel.
- SalesForce and SAP experience is a plus.
Vaccination Requirement: Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.
Compensation: The estimated hourly rate for this position is $33.41 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. Temporary associates will be paid by our approved providers.
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.