Quality Specialist II - Temporary

A typical day for the candidate involves actively supporting Quality Operations through a mix of hands-on floor engagement and strategic oversight. They begin the day by attending Tier 2 Gemba meetings and providing real-time support to manufacturing teams, ensuring compliance with quality standards. Their responsibilities include performing batch record reviews and product releases, reviewing and approving stability studies and labeling (such as FAI and field bulletins), and offering guidance on regulatory standards. The candidate also ensures training compliance, chairs Material Review Board (MRB) meetings, participates in Environmental Control Meetings, coordinates Quality Notifications (QNs), supports internal and external audits, and updates quarterly quality metrics. This role requires strong collaboration, attention to detail, and the ability to lead and influence cross-functional teams to uphold product and process integrity.

How You'll Make An Impact

• Driving Compliance and Risk Mitigation: QA Specialist IIIs are instrumental in ensuring that products and processes meet regulatory and internal quality standards.
• Enhancing Product and Process Quality: By reviewing batch records, managing quality documentation, and participating in root cause analysis, QA Specialist IIIs help identify and correct systemic issues.
• Acting as Subject Matter Experts: QA Specialist IIIs are designated as the primary experts for specific product regulatory compliance, in accordance with ISO13485 standards.
• Supporting Internal /External Audits - They play a key role in audit readiness , in the Bio-Rad requalification process, QA specialists coordinated responses to audit requests and ensured timely delivery of quality documentation
• Strategic Quality Planning- working independently while collaborating across departments. They audit and review quality data, implement standards, and document results in regulated formats
  
  

What You Bring

• Associate degree or equivalent in Biology, Chemistry, or a related field
• 2 years of experience in a regulated manufacturing industry, or an equivalent combination of education and experience
• Familiarity with GMP and quality system standards (e.g., ISO 13485, FDA 21 CFR 820/210/211)
• Working knowledge of device/drug/biotech manufacturing processes.
• Experience with nonconformance investigations, deviation management, batch record review, and product release
• Proficiency in QMS databases , SAP, Veeva and Microsoft Office
• Strong attention to detail, multitasking, time management, and communication skills.
  
  

Compensation: The estimated hourly range for this position is $40 to $43 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. 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.