Quality System Specialist II

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

Job summary

Bio-Rad Laboratories seeks a Quality System Specialist II to support quality management processes for life science and clinical diagnostics products. The role includes managing customer quality documentation requests, supporting product processes, and collaborating with sales teams. Applicants should have an associate degree in a related field and experience in a regulated environment.

Benefits

Competitive medical plans

401k plus profit sharing

Paid parental leave

Employee stock purchase program

Education benefits

Paid time off

Qualifications

• 1+ years experience in a regulated manufacturing industry or equivalent.
• Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).

Responsibilities

• Support customer quality documentation requests.
• Coordinate completion of supplier survey questionnaires.

Skills

Detail-oriented

Project management

Organization

Education

Associate degree or equivalent in Biology or Chemistry

Tools

Microsoft Office

SalesForce

SAP

Job description

Join to apply for the Quality System Specialist II role at Bio-Rad Laboratories

Join to apply for the Quality System Specialist II role at Bio-Rad Laboratories

Direct message the job poster from Bio-Rad Laboratories

Recruiting top talent that serve life science research and clinical diagnostics customers, helping people live longer, healthier lives.

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.

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

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

Referrals increase your chances of interviewing at Bio-Rad Laboratories by 2x

Sign in to set job alerts for “Quality System Specialist” roles.

QA Specialist - Minor Safety and Exploitative Content

Richmond, CA $84,300.00-$116,000.00 2 weeks ago

Quality Assurance Specialist, Financial Crimes

San Francisco, CA $40,000.00-$60,000.00 3 weeks ago

Alameda, CA $98,000.00-$196,000.00 1 hour ago

San Leandro, CA $70,500.00-$130,500.00 3 days ago

San Francisco, CA $170,000.00-$230,000.00 3 months ago

$29/hr - Autonomous Vehicle Operator (Testing and Quality Control)

San Francisco, CA $85,000.00-$130,000.00 3 weeks ago

San Francisco, CA $25.00-$30.00 3 months ago

QA Analyst - Specialty Mental Health Compliance & Billing Specialist

WAI (QA Department) Administrative Assistant

San Francisco, CA $130,000.00-$180,000.00 4 days ago

Pharmacist / Quality Control Data Specialist

Napa, CA $67,668.00-$74,616.00 9 hours ago

Senior Supplier Quality Engineer (Hybrid)

Fairfield, CA $90,000.00-$182,000.00 2 weeks ago

Credentialing Quality Assurance Specialist / Job Req 772071197

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.