Quality Control Support Specialist
Merck
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Benefits offered by this job
Job summary
Merck is building a new Quality Control organization in Boxmeer to support GMP compliance and operational excellence. The Quality Control Support Specialist will lead investigations, CAPA, and QC system processes within a growing facility dedicated to animal health products.
You will collaborate across functions to strengthen quality systems, support inspection readiness, and drive digitalization and QA initiatives in the new EU/FDA compliant plant, creating 80–100 roles as the site ramps up.
Qualifications
- Bachelor's degree in Life Sciences or related field.
- At least 4–6 years in a GMP-regulated pharmaceutical/biotech environment.
- Proven track record leading cross‑functional projects and driving continuous improvement.
- Strong knowledge of GMP regulations, quality systems, investigations, CAPA management, change control, qualification and validation processes.
- Solid understanding of QC laboratory operations, analytical methods and regulatory expectations.
- Experience with LIMS, SAP, computerized laboratory systems and digital quality management platforms.
- Strong analytical and problem‑solving skills with data trending and performance monitoring.
- Excellent project and stakeholder management, with influencing skills for cross-functional change.
- Demonstrated leadership, coaching and mentoring and strong technical writing.
Responsibilities
- Act as the QC SME for GMP compliance, quality systems, stability studies, LIMS implementation, and equipment lifecycle management.
- Lead investigations, deviations, root-cause analyses, and CAPA activities with timely resolutions.
- Own and drive quality system processes including change controls and audits.
- Review and approve GMP documentation: SOPs, protocols, validation documents, reports, and work instructions.
- Ensure QC operations comply with site procedures, global standards, and regulatory requirements.
- Lead qualification, validation, calibration and implementation for lab equipment and systems.
- Drive continuous improvement, digitalization, automation, and efficiency across QC and cross‑functional teams.
- Provide expert support to QA, Manufacturing and stakeholders on quality/compliance matters.
- Monitor data, trends and KPIs; translate insights into corrective actions and improvements.
- Lead cross‑functional projects, mentor colleagues, deliver GMP training, and represent QC during audits.
Skills
Education
Tools
Job description
This is a unique opportunity to help build a new Quality Control organization from the ground up, combining technical expertise, innovation, and leadership to support the future of animal health manufacturing in Boxmeer. Join us as a:
Our production facilities in Boxmeer are part of our global Animal Health production network and manufacture and package animal health products according to Good Manufacturing Practice standards (GMP). Currently, we are investing in a new EU and FDA compliant manufacturing facility, which includes a Quality Control laboratory, in Boxmeer to bring our latest animal health innovations to market. Once the manufacturing facility is fully operational (expected in 2030), it will create about 80-100 FTE jobs. The facility will include dedicated warehouse, manufacturing, quality assurance, quality control, and packaging & labeling teams to deliver high quality, compliant products.
The Quality Control Support Specialist is a senior technical expert within the Quality Control organization, playing a key role in ensuring GMP compliance, driving continuous improvement, and supporting operational excellence. Acting as a trusted Subject Matter Expert, you will collaborate across functions to strengthen quality systems, support inspection readiness, and contribute to the successful establishment and growth of the new Boxmeer West manufacturing facility.
- Act as the Quality Control Subject Matter Expert (SME) for GMP compliance, quality systems, stability studies, LIMS implementation, and laboratory equipment lifecycle management.
- Lead complex investigations, deviations, root cause analyses, and CAPA activities, ensuring timely and effective resolution.
- Own and drive quality system processes, including change controls, investigations, CAPAs, and compliance‑related initiatives.
- Review and approve GMP documentation, including SOPs, protocols, validation documents, technical reports, and work instructions.
- Ensure laboratory operations comply with site procedures, global standards, and regulatory requirements, maintaining inspection readiness at all times.
- Lead and support qualification, validation, calibration, and implementation activities for laboratory equipment, systems, and new technologies.
- Drive continuous improvement, digitalization, automation, and efficiency projects across Quality Control and cross‑functional teams.
- Provide expert support to laboratory operations, Quality Assurance, Manufacturing, and other stakeholders on quality and compliance matters.
- Monitor laboratory data, trends, and performance metrics, translating insights into actions that enhance quality, compliance and operational excellence.
- Lead cross‑functional projects, mentor colleagues, deliver GMP training, and represent Quality Control during audits
- Bachelor's degree in Life Sciences, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences or a related field.
- At least 4-6 years experience in a GMP-regulated pharmaceutical, biotechnology or life sciences environment.
- Proven track record of leading cross‑functional projects and driving continuous improvement initiatives.
- Strong knowledge of GMP regulations, quality systems, investigations, CAPA management, change control, qualification and validation processes.
- Solid understanding of Quality Control laboratory operations, analytical methods and regulatory expectations.
- Experience working with LIMS, SAP, computerized laboratory systems and digital quality management platforms.
- Strong analytical and problem‑solving skills, with experience in data analysis, trending and performance monitoring.
- Excellent project management, stakeholder management and influencing skills, with the ability to drive change across functions.
- Demonstrated leadership, coaching and mentoring capabilities, combined with strong technical writing
- Excellent verbal and written communication skills in Dutch and English.
- The opportunity to step into a new, hands‑on position where you'll work independently, collaborate across functions and take on real leadership responsibilities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
- Competitive salary based on your knowledge and experience.
- 3% year-end payment and an annual bonus based on personal and company performance.
- At least 35.5 days of paid leave.
- Travel allowance and a solid pension scheme.
- A high‑quality company restaurant offering fresh and healthy options daily.
- Excellent accessibility: the train station is located directly at our main entrance and there is ample parking available.
- A contribution toward your personal sports membership to support your vitality.
- A beautiful private park on the premises, ideal for a walk, break, or moment of rela
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