Quality System Specialist II

Bio-Rad Laboratories, Inc; Hercules (CA); On-site; USD 75,000 - 104,000; Full time

Job summary

A leading company in the life sciences sector seeks a Quality System Specialist to support quality management for their products. This role includes onboarding suppliers, managing customer documentation requests, and ensuring compliance with regulatory standards. The successful candidate will leverage their knowledge of GMP/ISO regulations and project management skills while contributing to the overall quality objectives of the organization.

Benefits

Competitive medical plans

401k plus profit sharing

Paid parental leave

Extensive learning and development opportunities

Employee stock purchase program

Paid time off

Qualifications

• 1+ years experience in a regulated manufacturing industry is required.
• Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Working knowledge of device/drug/biotech manufacturing processes.

Responsibilities

• Support the management and closure of customer quality documentation requests.
• Facilitate the onboarding of Bio-Rad as a supplier to key customers.
• Coordinate product certificate requests and quality agreements.

Skills

Detail-oriented

Excellent organization

Project management skills

Multitasking ability

Education

Associate degree in Biology, Chemistry, or related field

Tools

Microsoft Office

Visio

Excel

SalesForce

SAP

Job description

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.

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:

• Education: Associate degree or equivalent in Biology, Chemistry, or related field.
• Work Experience: 1+ 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.
• Proficient in Microsoft Office, Visio and Excel SalesForce and SAP experience is a plus.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Compensation: The estimated base salary range for this position is $75,500 to $103,900 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. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

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. 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.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-AK1 #LI-Hybrid

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.