Merck & Co.

Job Description

An amazing opportunity has arisen for a QA Operations Specialist (Shift). This role will be a part of our QA Operations Self Directed Work Team (SDWT) in our state-of-the-art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.

The QA Operations Specialist role involves supporting the operational activities, technical transfers, regulatory approvals and commercial/clinical operations at the single use multi-product biotech facility. The individual will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.

The QA Operations Specialist will be responsible for supporting the Operations team, ensuring compliance with cGMP and corporate regulations.

Important: The individual must be able to work on his/her own initiative in addition to working as part of a team and must be able to work 24/7 shift. Current Shift Pattern is 16/7 but subject to change. Must be able to work across a team matrix in order to meet accelerated timelines.

What you will do:

Bring your energy, knowledge, and innovation to:

• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations, Quality Control, Engineering and Supply Chain.
• Review and approval of Manufacturing batch records.
• Liaises with internal partners (e.g. Manufacturing Operations, Manufacturing & Science Technology (MS&T), Engineering functions etc) in support of daily operations.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ability to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.

What skills you will need:

To excel in this role, you will have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• 4+ years experience in QA or related function.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Demonstrated collaboration, negotiation & conflict resolution skills.
• Excellent communication skills (written and oral).
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Experience in performing internal audits and participating in external audits.
• Exceptional analytical, problem solving & root-cause analysis skills.
• Ability to multi-task and handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Experience with working in a multinational organisation.
• Strong operations support background ensuring value added and effective quality oversight

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, 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.

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):

Required Skills:

Aseptic Manufacturing, Aseptic Manufacturing, Audits Compliance, Conflict Resolution, Corrective and Preventive Action (CAPA), Design Controls, Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Inspection Readiness, Management Process, Operations Support, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management, Quality Management System Auditing, Quality Management System Improvement, Quality Management Systems (QMS), Quality Standards, Regulatory Compliance, Risk Management, Root Cause Analysis (RCA), Social Collaboration {+ 3 more}

Preferred Skills:

Job Posting End Date:

07/4/2025

• 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.