Quality Assurance Associate Specialist

Job Description

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to several state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the Southeast region and attracts high performing talent through close collaborations with universities and colleges in the region.

Our Carlow site has another great opportunity for a Quality Assurance Associate Specialist within IPT. Reporting to the Quality Manager, you will provide essential QA oversight and support across the site.

What you will do:

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

Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.

Review and approval of SOPs, cleaning verification/validation data and other documents as necessary for the IPT department.

Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.

Support the development and implementation of improved quality reporting measures.

Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.

Actively participate in Plant/Quality committees and works with other site functional

groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and

Maintenance to help set direction for plant wide GMP initiatives.

Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations.

Provide quality support across the site, including training and guidance on company guidelines, policies, and regulatory interpretation.

Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project, basis including communications, training, project work,

audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring IPT is audit/inspection ready.

Initiate and maintain quality related metrics, ensuring effective communication and

follow up of same, including Monitoring of quality systems, the self-inspection program, verification of the effective implementation of key GMP programs, effectiveness of Preventative Actions.

Leadership activities including selection, development, coaching, and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs.

Work collaboratively to drive a safe and compliant culture in Carlow.

Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.

The above list of duties is not an exhaustive list

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

Degree in Science, Engineering or in a relevant disciplineORequivalent experience with operational excellence in GMP environment

A minimum of 3 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or manufacturing

Working knowledge of regulatory and code requirements pertaining to Irish, European, and International Codes, Standards, and Practices.

Knowledge of cGMP and GDP is essential.

Proficiency in report writing, standards development, and policy writing.

Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

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

Required Skills:

Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Complaint Management, Compliance Programs, Continuous Process Improvement, Decision Making, Deviation Management, Documentation Review, GMP Compliance, Good Manufacturing Practices (GMP), Operational Efficiency, Production Operations, Quality Auditing, Quality Management, Quality Management Standards, Quality Management System Auditing, Quality Management System Improvement, Quality Management Systems (QMS), Quality Standards, Quality Support, Regulatory Requirements, Root Cause Analysis (RCA), Technical Writing, Training and Development

Preferred Skills:

Current Employees applyHERE

Current Contingent Workers applyHERE

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:

07/20/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.

Requisition ID: R398536