Associate Specialist Quality Control

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)

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/19/2026

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