Quality Assurance Specialist II Full Time NEW

ABOUT

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.

With over 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. We are looking to take Vector Laboratories to new heights and hope you’ll consider joining our globally impactful team!

JOB SUMMARY

The QA Specialist II, reporting to the Director of Quality, will be responsible for overseeing the processes related to Product Release, Deviations, Nonconformances (NCM), and Change Control. The successful candidate will work proactively with teams in Production, Operations, Product Management, and Customer Service to ensure compliance and continuous improvement of our Quality Management System.

The qualified individual will manage quality events such as deviations, nonconformances, corrective and preventative actions (CAPAs), and escalated complaints. Additionally, they will perform batch reviews for product release and support other quality system processes. This is a highly visible, hands-on position that requires the ability to work both independently and as part of a team.

Travel Note: This position requires occasional (likely quarterly) travel to the Susteren, Netherlands site for QA support and inspection.

RESPONSIBILITIES

• Review batch records and authorize product releases in our ERP system (NetSuite).
• Track deviations, nonconformances, and complaint investigations, including coordinating root cause analyses and following up on the implementation and effectiveness of corrective and preventive measures.
• Assist operational teams in initiating change requests by analyzing the risk impact and coordinating with stakeholders to process the change request.
• Responsible for maintaining eQMS software (Dot Compliance), serving as the administrator across all Vector UK and Netherlands sites.
• Support the filing and management of controlled quality records.
• Report and analyze monthly quality system metrics from Excel logs and the electronic QMS.
• Support quality improvement projects by planning, developing, and communicating action plans, as well as providing regular project updates.
• Lead and support customer audits, internal audits, and certification audits.
• Promote our quality culture by supporting training initiatives and ensuring personnel understand our QMS.
• Perform other related duties as assigned.

QUALIFICATIONS

Required

• Minimum 2 years of direct experience in Quality Assurance supporting Deviation / NCM / Change Control and CAPAs.
• Strong knowledge of ISO 9001 requirements.
• Minimum BS Degree in Bioscience, Chemistry, or similar science discipline.

Preferred

• Experience with NetSuite ERP and managing eQMS software (e.g. DOT Compliance).
• ISO 9001:2015 or ISO 13485:2016 certified auditor.

Skills

• Strong organizational skills and ability to support multiple quality projects simultaneously.
• Excellent verbal and written communication skills.

COMPETENCIES FOR SUCCESS

Passionate About Problem-Solving

As a results-oriented self-starter, you are eager to leverage your expertise in identifying inefficiencies, analyzing root causes, and recommending effective solutions.

Collaborative & Independent

You will collaborate across various teams, including engineering, production, QC, product development, and customer service. As the QA representative, you will actively contribute to discussions on risk analysis, QMS process guidance, and proposed solutions.

Proactive & Personable

You will initiate communication and establish strong relationships with colleagues to support the implementation of the QMS system.

Project Coordination

You will be responsible for tracking multiple quality metrics and providing timely updates.

Credible

You will serve as a role model of the ISO 9001 Principle: “Say what you do and do what you say.”