Quality Specialist

We are seeking a QA Specialist for a 6-month contract (with likely extension) to support the strengthening and execution of Quality Assurance operations at a dynamic biotech manufacturing site. The role is focused on QA systems oversight, vendor management, and hands-on delivery of operational quality tasks. This is a part-time role (32 hours/week), with on-site presence required ideally 4 days per week (3 days possible).

You will work as part of a collaborative QA team, directly contributing to system improvements, audit readiness, and routine compliance activities in a fast-paced, GMP-regulated environment.

Company Description:
The company values a hands-on, team-oriented approach and is committed to continuous improvement of its QMS and compliance framework. You’ll operate within a close-knit QA team of 8 professionals, where your ability to drive progress and execute will have visible impact.

Essential Requirements:

• 2–5 years of experience in QA within a biotech manufacturing environment

• Strong foundation in QA systems, SOP management, and QMS improvement

• Demonstrated experience with PQRs, CAPAs, change controls, and deviation handling

• Fluency in Dutch is strongly preferred (exceptional non-fluent candidates will be considered)

• Experience in vendor management, including attaching KPIs and monitoring performance

• Proactive, execution-oriented mindset – focused on practical delivery and problem-solving

• Ability to work independently and contribute within a team of 8 QA professionals

Desirable Requirements:

• Experience working in smaller, agile manufacturing settings (e.g., HAL, Batavia, NecstGen)

• Prior exposure to QA preparation for inspections or audits

• Skilled in operational QA activities beyond documentation (e.g., on-floor quality oversight)

• Familiarity with risk-based thinking and continuous improvement culture

Additional Insights:

• Start Date: ASAP – ideally 1st or 15th October

• Duration: Initial 6-month contract (extension highly likely)

• Employment Type: Contractor

• Hours: 32 hours/week (4 days)

• On-Site Presence: Ideally 4 days/week (minimum 3 days possible)

• Interview Process: 1-stage interview, with preferred scheduling of 3 strong candidates back-to-back later in the day