Associate Specialist Quality Control

MSD Malaysia; Carlow; Hybrid; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

MSD Carlow is seeking an Associate Specialist in Quality Control to support QC operations, documentation, deviations, investigations, and cGMP compliance across the manufacturing site. The role emphasizes data integrity, Right First Time, and effective document lifecycle management.

You will contribute to NPI, tech transfers, and lifecycle activities from a QC perspective, review testing documentation, and mentor colleagues in compliant documentation and continuous improvement.

Qualifications

• Bachelor's degree in Analytical Chemistry/ Biochemistry or closely related field.
• 4+ years of cGMP Quality Control experience in pharma/biopharma.
• Experience with HPLC and ELISA systems and related software.

Responsibilities

• Perform and support QC activities with data integrity and QMS alignment.
• Review testing documentation and ensure regulatory compliance and QA readiness.
• Support deviation investigations using root cause analysis and CAPA.
• Assist with NPI, tech transfers, and lifecycle QC activities.
• Mentor peers to prepare compliant, high‑quality documentation.

Skills

ELISA

GMP

HPLC

Regulatory compliance

Quality systems

Education

Bachelor's degree in Analytical Chemistry/ Biochemistry

Tools

LIMS

ELN systems

Job description

## Associate Specialist Quality ControlApply: Not Applicable: IRL - Carlow - Carlow: Full time: Posted Today: End Date: October 19, 2026 (12 days left to apply): R419947Job DescriptionOur Carlow site, which broke ground in 2008, is a strategic manufacturing facility supporting the launch and commercial supply of vaccines, biologics, and small molecule drug products.Since its establishment, the site has benefited from significant investment and is home to state-of-the-art manufacturing facilities, laboratories, and temperature-controlled warehousing. As a major employer in the Southeast region, the Carlow site attracts high-performing talent through strong collaborations with local universities and colleges.Due to growth, we have openings for 4 Quality Control Associate specialists to join the team.The Quality Control Associate Specialist is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP). The role provides technical expertise in QC documentation, investigations, and continuous improvement to support robust product quality and reliable supply.### **Bring energy, knowledge, and innovation to carry out the following:*** Execute and support QC activities in alignment with company Global Policies, Procedures, and the Global Quality Management System.* Ensure compliance with applicable regulatory requirements and cGMP expectations across all assigned activities.* Demonstrate a strong culture of quality, data integrity, and inspection readiness.* Review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved* Act as a subject matter expert for QC documentation systems, ensuring effective document lifecycle management, workflow efficiency, and timely approvals.* Facilitate and mentor others in the preparation of compliant, high‐quality documentation.* Support QC laboratory operations through generation, review, and management of GMP documentation associated with routine operations and atypical events.* Support new product introductions (NPI), technology transfers, and lifecycle activities from a QC compliance and documentation perspective.* Support deviation and investigation activities using structured root cause analysis tools (e.g. FMEA, Fishbone, 5‐Whys).* Drive continuous improvement by identifying trends, system gaps, and opportunities to strengthen QC processes.* Maintain current knowledge of Irish, European, and international regulatory expectations relevant to Quality Control operations**What Skills You Will Need*** Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline* 4 years of experience cGMP Quality Control and quality systems within a regulated pharmaceutical or biopharmaceutical environment.* Demonstrated experience of HPLC/ELISA systems and softwareWe keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.We are committed to flexible working wherever possible and have introduced a hybrid working model for eligible office-based employees. We encourage candidates to discuss any flexibility requirements during the recruitment process.**Required Skills:**ELISA Test, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), International Regulatory Compliance, Laboratory Quality Control, Quality Management Systems (QMS)