Associate Specialist Quality Control

Msd Ireland; Carlow; Hybrid; EUR 40,000 - 60,000; Full time

Job summary

Merck & Co., Inc. is seeking a Quality Control Associate Specialist at our Carlow site. The role supports QC operations and quality systems to ensure adherence to cGMP, regulatory requirements, and company standards, delivering robust product quality and reliable supply.

You will mentor colleagues in compliant documentation, support GMP documentation, and assist with NPI, technology transfers, and lifecycle activities from a QC perspective. A hybrid work model is offered where possible.

Qualifications

• 4 years of cGMP QC experience in a regulated pharma/biopharma environment.
• Demonstrated experience with HPLC/ELISA systems and associated software.
• Bachelor's degree or higher in Analytical Chemistry, Biochemistry, or related discipline.

Responsibilities

• Execute and support QC activities aligned with Global Policies and the Global Quality Management System.
• Ensure cGMP compliance and regulatory expectations across activities.
• Demonstrate strong data integrity culture and inspection readiness.
• Review testing documentation to ensure data integrity and QC Right First Time KPIs.
• Serve as subject matter expert for QC documentation systems and lifecycle management.

Skills

ELISA

GMP

HPLC

Regulatory compliance

Quality systems

QMS

Education

Bachelor's degree in Analytical Chemistry/Biochemistry

Tools

HPLC

ELISA

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

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.

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)

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

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.

Requisition ID

R419947