Quality System Specialist II

The Quality System Specialist II will play a key role in supporting manufacturing activities at the Life Science Group site on the Richmond campus. Activities will primarily include supporting product release and process nonconformance and deviation management including follow-up & liaison with applicable department assignees. The day starts with meeting with Manufacturing to understand the daily objectives. Throughout the day, Batch record review and Quality Notification process dominates 75% of the activities.

The remaining 25% is split for change control, complaint support, audit support, and other QA initiatives.

• Timely Product releases from mfg to distribution
• Escalate relevant issues to the right department for proper resolution
• Correct processing of Quality Notifications (Deviations and Non-conformances)
• Support regulatory and customer audits including inspection preparation activities and audit responses
• Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)

• 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 experience is a plus.

This position must be based in Richmond, CA and requires the employee to be located within commuting distance of the office.

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, 401(k) 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!

The estimated base salary range for this position is $77,600 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.

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.