Quality Assurance Specialist II

6737 Mowry Avenue | Newark, CA 94560 | vectorlabs.com Employee Job Description Job Title: Quality Assurance Specialist II Department: Quality Assurance About Vector Laboratories Vector Laboratories is seeking a talented and highly motivated individual to join our growing team. As an organization known for its culture of service, reliable products and unmatched technical expertise, our employees are passionate about the impact and quality of their work. The opportunities we provide to work collaboratively and build trusting relationships in a team -oriented environment make Vector Laboratories an ideal place to learn, flourish and contribute to scientific advancement. We genuinely value diverse perspectives and ideas and strive to demonstrate how this approach results in success. With nearly 50 years of history, Vector Laboratories boasts an unparalleled reputation in protein labeling, detection, and conjugation. Our recent mergers and acquisitions have significantly expanded our portfolio, serving the biopharma industry, academia, life science tools, and diagnostics, providing comprehensive solutions to the life science industry. We are looking to take Vector Laboratories to new heights and hope you'll consider joining our globally impactful team! Job Summary The Quality Specialist II is a global Qua lity Assurance role responsible for supporting product release and key Quality Management System (QMS) processes, including deviations, nonconformances (NCM), CAPA, complaints, and change control, for the Plain City, Ohio, US manufacturing site and the Red car, UK site. The role partners cross -functionally with Production, Operations, Product Management, and Customer Service to ensure compliance, drive timely issue resolution, and strengthen a culture of quality and continuous improvement. The position manag es quality events from initiation through closure (e.g., deviations, nonconformances, CAPAs, and escalated complaints), including investigation support, facilitation of root cause analysis, and verification of the effectiveness of corrective and preventive actions. The role also performs batch record reviews for product release and provides hands -on support for other QMS activities at the Plain City, OH site, while coordinating remotely with the UK site. This is a hybrid role with an on -site expectation of 4 days per week at our Plain City, Ohio site, and remote support for Quality Operations at the UK site. This position reports to the Director of Quality Assurance. Note: This is a hybrid role requiring 4 days per week on -site at Plain City, Ohio, with 10% travel to other Vector locations. Competencies Identified for Success Passionate About Problem -Solving As a results -oriented self -starter, eager to leverage expertise in identifying inefficiencies, analyzing root causes, and recommending effective solutions. Ability to Work Independently and as Part of a Team Collaborates across teams, including engineering, production, quality control (QC), product development, and customer service. As the QA representative, actively contributes to discussions on risk analysis, QMS process guidance, and proposed solutions. Proactive and Personable Initiates communication and establishes strong relationships with colleagues to support the implementation of the QMS system. 6737 Mowry Avenue | Newark, CA 94560 | vectorlabs.com Project Coordination Responsible for tracking multiple quality metrics and providing timely updates. Credible Serves as a role model of the ISO 9001 principle: "Say what you do and do what you say." Responsibilities • Review batch records and approve product release in the ERP system (NetSuite) in accordance with established procedures. • Own and track deviations, nonconformances (NCM), and complaint investigations from initiation to closure, including coordinating root cause analysis and ensuring timely, effective CAPA implementation. • Support change control by partnering with operational teams to initiate change requests, perform risk/impact assessment, and coordinate stakeholder reviews through implementation and closure. • Administer the electronic QMS (Dot Compliance), including user ad ministration, workflow configuration support, and day -to-day system troubleshooting for the Ohio and UK sites. • Maintain controlled quality records, ensuring accurate filing, version control, retention, and retrieval in accordance with record control requir ements. • Compile, trend, and report monthly QMS metrics using Excel logs and eQMS data; escalate adverse trends and recommend improvement actions. • Support quality improvement initiatives by developing action plans, tracking deliverables, communicating statu s, and driving timely completion of agreed actions. • Prepare for and support customer, internal, and certification audits, including hosting audit activities, coordinating responses, and tracking corrective actions to closure. • Promote a strong quality culture by supporting QMS training, coaching cross -functional partners on process requirements, and reinforcing compliance expectations. • Performs other duties as assigned to support the Quality Assurance function. Job Qualifications • Minimum 2 years of di rect experience in Quality Assurance supporting Deviation/NCM/Change Control and CAPAs (required). • Strong knowledge of ISO 9001 requirements (required). • Minimum BS Degree in Bioscience, Chemistry, or a similar science discipline (required). • Experience with NetSuite ERP and managing eQMS software, e.g. Dot Compliance (preferred). • ISO 9001:2015 or ISO 13485:2016 certified auditor (preferred). • Strong organizational skills and ability to support multiple quality projects simultaneously. • Excellent verbal and wri tten communication skills. Compensation The anticipated salary range for this position is $65,489.00 - $72,765.00. The salary offer will depend on multiple factors, including the successful candidate''s skills, experience, and other qualifications.