Job Description

Our Biologics facility in Dunboyne have a great opportunity for a QA Operations Specialist to join the team.

Reporting to the QA Operations Manager within Global Development Quality (GDQ), the QA Specialist role will support the Quality Assurance activities at Research & Development Division facility.

You will be a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.

Please note this is a shift role.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

What skills you will need:

Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner.
Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented to meet deadlines.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements.
Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations.
Perform material disposition of incoming material to the site.
Assist in the development of training curricula and records for the QA Operations group, providing SME training on Quality Assurance SOPs as required.
Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
Participate in and support risk management activities in line with relevant guidance and best industry practice.
Ensure the escalation of compliance risks to management in a timely manner.
Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
Support cross functional departments by responding to quickly to unplanned events and technical issues.
Perform real time exception review by maintaining on the floor operations support during manufacturing.
Support the site’s walk-through/ GEMBA process as assigned.
Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.

In order to excel in this role, you will more than likely have:

Degree qualification (Science/Quality/Technical).
4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
Experience with PAS-X, SAP and Veeva is desirable.
Project Manager capability with significant understanding of Operations and/or Laboratories.
Demonstrated experience in QRM, Investigations, problem solving as a Quality SME.
Strong written and verbal communication skills.
Ability to think logically and be proactive under pressure.
Ability to work as part of a team and on own initiative in a constructive manner.
Strong attention to detail and precision in preparing and reviewing GMP documentation.
Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Experience in direct interactions with regulatory agencies during site inspections.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Partner assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Aseptic Manufacturing, Audits Compliance, Communication, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management, Test and Evaluation (T&E), Troubleshooting

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:

03/19/2026

*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:R385923