Quality Assurance (QA) Specialist (36-40h/wk)

MRC Holland; Amsterdam; On-site; EUR 47,809 - 50,900; Full time

Benefits offered by this job

28 holidays a year

Full reimbursement for public transport

Excellent pension scheme

Health insurance reimbursement

Sports subscription reimbursement

Job summary

MRC Holland, located in Amsterdam, is seeking a QA Specialist to oversee quality assurance processes within their biotechnology operations. This role involves implementing QA procedures, training staff, and collaborating on product design reviews.

The ideal candidate has a BSc in Biology or related fields, with over 3 years of proven experience in the biotech or pharmaceutical industries. Benefits include competitive salary, extensive holidays, and a robust pension scheme.

Qualifications

• 3+ years of relevant working experience in the medical device, pharmaceutical, and/or biotech industries.
• Fluent written and spoken English; Dutch preferred.
• Currently reside in the Netherlands and hold a valid working permit.

Responsibilities

• Process owner of certain QA processes.
• Implementing and updating QA procedures.
• Training functionaries.
• Monitoring and providing trend-analysis of QA procedures.
• Represent in product design reviews.
• Conduct internal auditing.
• Lead and support QA-related projects.

Skills

Analytical skills

Knowledge of ISO 13485

Knowledge of genetics

Organizational skills

Proactive and self-motivated

Ability to manage multiple tasks

Education

BSc degree in Biology, Biomedical Sciences or equivalent

Job description

MRC Holland is a biotechnology company located in Amsterdam, Netherlands, developing and manufacturing solutions for genetic inquiries, including MLPA®, digitalMLPA™, and a Melt Assay for newborn screening.

Key Responsibilities

• Process owner of certain QA processes
• Implementing and updating QA procedures
• Training functionaries
• Monitoring and providing trend‑analysis of QA procedures as input for the Management Review
• Work and assist colleagues in other QA processes
• Represent in product design reviews as part of a Design Team and responsible for QA‑related design project deliverables and documentation
• Product/Batch Release
• Internal Auditing
• Collaborate with interdisciplinary teams to stimulate and support continuous improvement
• Lead and support QA‑related projects

Qualifications

• BSc degree in Biology, Biomedical Sciences or equivalent
• 3+ years of relevant working experience in the medical device, pharmaceutical and/or biotech industries
• Adequate knowledge of ISO 13485, ISO 14971 and basic knowledge of international IVD regulations (e.g., EU 2017/746)
• Adequate knowledge of genetics
• Fluent written and spoken English (Dutch language is not required, but preferred)
• Well‑developed analytical skills
• Affinity with procedures and processes
• Pragmatic, pro‑active and self‑motivated
• Strong organizational skills, flexible, ability to manage multiple tasks and attention to detail
• Able to work alone as well as part of a team
• Currently reside in the Netherlands and hold a valid working permit

Benefits

We offer a great position in a medium‑sized, flexible organization with a multicultural workplace and a high level of independence and professionalism.

• Starting salary: €4,284‑€4,561 (based on 40‑hour contract)
• 28 holidays a year, plus closure between Christmas and New Year's Day
• Full reimbursement for public transport travel
• Excellent pension scheme
• Extensive collective health insurance with reimbursement from MRC Holland
• Maximum €25/month reimbursement for sports subscription; participation in yoga classes or chair massage available