Quality System Specialist II

About the role

The Quality System Specialist II will support manufacturing activities at the Life Science Group site on the Richmond campus. Key responsibilities include supporting product release and process nonconformance and deviation management, reviewing batch records, and managing the Quality Notification process.

Responsibilities

• Timely product releases from manufacturing to distribution
• Escalate relevant issues to the right department for proper resolution
• Correctly process Quality Notifications (Deviations and Non-conformances)
• Support regulatory and customer audits including inspection preparation activities and audit responses
• Rapid containment of product quality issues (from manufacturing issues or customer complaints)

Requirements

• 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 a 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 processes
• Regulatory: Able to understand GMP and regulatory requirements applicable to US FDA and ISO standards
• Data-driven: Able to retrieve data and organize them for analysis and conclusions
• Interested: Able to learn and eager to learn more about the product, process, workflows to foster an environment of continuous improvement
• Detail-oriented and able to multitask based on priority
• SAP experience is a plus

Qualifications

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

Benefits

Total Rewards Package includes competitive medical plans, HSA funds, fertility offering, group life and disability, paid parental leave, 401k plus profit sharing, employee stock purchase program, mental health platform, 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!

Pay

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.

Schedule

This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.