Associate Specialist Quality Control

MSD Malaysia; Carlow; On-site; EUR 55,000 - 70,000; Full time

Job summary

MSD is hiring a Quality Control Associate Specialist at our Carlow site to support QC operations, investigations, and documentation in a cGMP environment. The role focuses on ensuring data integrity, regulatory compliance, and timely approvals of QC documentation.

Ideal candidates hold a Bachelor's or higher in Analytical Chemistry/Biochemistry with at least 4 years in cGMP QC, and hands-on experience with HPLC/ELISA systems and related software.

Qualifications

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

Responsibilities

• Execute and support QC activities per Global Policies, Procedures and QMS.
• Ensure compliance with regulatory requirements and cGMP expectations.
• Maintain data integrity and inspection readiness.
• Review testing documentation and ensure data integrity and QC KPIs.
• Act as SME for QC documentation systems and lifecycle management.
• Mentor others in preparing compliant, high‑quality documentation.
• Support QC lab operations and GMP documentation for routine and atypical events.
• Support NPI, technology transfers and lifecycle activities from QC perspective.
• Assist deviation/investigation activities using root cause tools (FMEA, Fishbone, 5‑Why).
• Drive continuous improvement by identifying trends and gaps in QC processes.
• Stay updated on Irish/European/international regulatory expectations.

Skills

ELISA

GMP

HPLC

Regulatory compliance

Quality Control

QMS

Education

Bachelor's degree or higher in Analytical Chemistry/Biochemistry

Job description

Job Description

Our 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 software

Responsibilities

• 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.

Required Skills

• ELISA Test
• Good Manufacturing Practices (GMP)
• High-Performance Liquid Chromatography (HPLC)
• International Regulatory Compliance
• Laboratory Quality Control
• Quality Management Systems (QMS)

We 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.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/19/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.