Quality System Specialist II

As a Quality System Specialist II, you play a vital part in supporting manufacturing operations at the Clinical Diagnostics Group site on the Hercules campus. Your main responsibilities involve overseeing product release, managing process nonconformance and deviation issues, and coordinating with the relevant departmental staff. Each day begins with a meeting with the Manufacturing team to review the day's goals. Most of your time-about 75%-is dedicated to batch record reviews and handling non-conformance processes. The other 25% of your day is divided among change control activities, audit support, and various quality assurance initiatives.

How You'll Make An Impact:

• Review and approve batch records and related documentation.
• Support investigations for non-conformances and deviations.
• Collaborate with Operations to implement corrective and preventive actions.
• Maintain compliance with ISO, FDA, and other applicable regulations.
• Assist in internal audits and regulatory inspections.
• Escalate relevant issues to the right department for proper resolution.
• Correct processing of Deviations and Non- conformances.
• Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue).

What You Bring:

• Education: Associate degree or equivalent in Biology, Chemistry, or related field.
• Work Experience: 4+ years experience in a regulated industry or equivalent combination of education and experience.
• Self- driven: no need to be micro - managed and can have personal initiative to prioritize work activities.
• Team player: have general positive personality and work well with others, especially outside the department.
• Quality Mindset: Can understand the risk or impact of an issue to other process(es).
• Regulatory: Able to understand GMP and regulatory requirements applicable to US FDA and ISO standards.
• Data- driven: Able to retrieve data and organize them, to allow for analysis and conclusion.
• Interested: Able to learn and eager to learn more about the product, process, workflows to foster an environment of continuous improvement.
• Detailed oriented and ability to multi- task based on priority.
• SAP /Veeva/Power BI 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 $76,600 to $106,700 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