QA Operations Specialist

Job Description

An amazing opportunity has arisen for a Quality Operations Specialist, at our newest state-of-the-art, fully integrated vaccine facility in Dundalk.

This role provides direct quality support and oversight to manufacturing operations as part of an integrated cross-functional team. With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures the quality and compliance of products manufactured on site, adherence to Good Manufacturing and Documentation Practices, and represents quality directly on the shop floor across Drug Product and Drug Substance GMP manufacturing.

What you will do

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

• Responsible for the review and approval of new and updated Master Batch Records and Electronic Batch Records.
• Review and approve production documentation, such as executed electronic batch records and logbooks, to ensure accuracy and compliance with current Good Manufacturing Practice and company procedures.
• Maintain an active presence on the shop floor to support compliance, data integrity, and right-first-time manufacturing.
• Review and approve new and updated Standard Operating Procedures, work instructions, and controlled job aides.
• Actively participate in the site Tier process, using this forum to make quality matters visible and to partner with operational areas on swift resolution.
• Provide Quality Assurance support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Serve as the Quality Subject Matter Expert for Performance Qualification activities across the site, including equipment, clean utilities, facility qualification studies, Cleaning Validation, Sterilise-in-Place, and process validation.
• Participate as an active, collaborative quality partner on site cross-functional projects.
• Support sustaining activities such as change control management, deviation investigations, Corrective and Preventive Actions, equipment requalification, periodic reviews, and the site maintenance and calibration programme.
• Provide direct support to internal audits and external regulatory inspections, fostering ongoing inspection readiness.
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
• Drive continuous improvement and utilise structured problem-solving tools to enhance operational efficiency, resolve issues, and promote a proactive quality culture.

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 (such as Biotechnology, Microbiology, or related Life Sciences).
• Minimum 3 years of relevant experience in a regulated Good Manufacturing Practice manufacturing, Quality Assurance, or laboratory environment.
• Practical working knowledge in the biopharmaceutical or vaccine industry, specifically within Quality Assurance operations.
• Strong interpersonal skills, including flexibility, empathy, collaboration, and the proven ability to thrive in an inclusive team environment.

Preferred

• Experience with Quality Management Systems, pharmaceutical manufacturing or laboratory processes, and authoring and approving Good Manufacturing Practice documents. Advantage if participated to the implementation, deployment of QMS.
• Demonstrated analytical aptitude, critical thinking skills, and practical problem-solving capabilities.
• Demonstrated leadership qualities with strong, constructive oral and written communication abilities.
• Bioprocessing knowledge, aseptic manufacturing experience, or technical transfer familiarity.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

Our Companies inIreland is one of the country’s leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operatesubstantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.

Required Skills

Audit Readiness, Change Controls, Deviation Management, Documentation Review, Good Manufacturing Practices (GMP), Quality Management Systems (QMS), Quality Operations

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

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 inclusive, talented, and committed people together.

So, if you are ready to

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

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

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