QA Operations Specialist

Job Description

An amazing opportunity has arisen for a QA Operations Specialist, in our Biotech facility, in Dublin.

This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.

This is a shift role (4 x 12hr extended days followed by 4 days off).

What you will do:

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

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures 
• Provides presence on the shop floor to support compliance and data integrity
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
• Participates as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools. Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

What skills you will need:

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

Required

• Bachelor’s degree in a scientific or engineering field (preferred) or significant relevant experience in other fields.
• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environment.
• Expertise with at least 2 years of working knowledge in the biotech industry, specifically in QA operations.
• Strong interpersonal skills, including flexibility, collaboration, and the ability to work in a team environment.

Preferred

• Experience with Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
• Demonstrated analytical aptitude, critical thinking skills, and problem-solving skills
• Demonstrated leadership skills with strong oral and written communication abilities
• Bioprocessing knowledge, upstream and or/ downstream

Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from our Company in Ireland to the world.

Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, Dundalk, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company’s top products, helping save and enhance lives in over 140 countries around the world.

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then.  The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

If you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills:

Automation Testing, Capital Projects, Communication, Critical Thinking, GMP Compliance, Good Manufacturing Practices (GMP), Mentorship, Operational Efficiency, Pharmaceutical Manufacturing, Problem Solving, Production Support, Quality Management, Quality Operations, Regulatory Compliance, Regulatory Requirements

Preferred Skills:

Business Development, Curriculum Development, Development Coaching, Development Communication, Education Policy Development, Leadership Initiatives, Learning Assessments, Learning Management, Learning Strategies, Management Development, Professional Development, Project Management Training, Strategy Development, Training Programs

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:

04/13/2026

*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.