Quality Assurance Specialist

Job Description

An amazing opportunity has arisen for a Quality Systems Specialist to join our team at our Dunboyne facility. The successful candidate will be responsible for maintenance and continuous improvement of the Quality Management System (QMS). The Quality Systems Specialist will play a crucial role in ensuring compliance with regulatory requirements and driving continuous improvement in our quality systems.

The main area of focus for this role is, but not limited to, documentation management and QMS implementation.

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

• Operate and manage the documentation management systems including periodic review, documentation obsoletion and user access.
• Manage the Documentation Archiving System, including issue and reconciliation of controlled documentation.
• System owner for electronic logbook system (eLogs) including template approval, periodic review and system access.
• Site topic owner for QMS and SOP Lifecycle Management including management of local QMS assessments and implementation reports.
• Generate and provide compliance metrics.
• Provide quality support to the site, including training and guidance on QMS systems.
• Perform QA review of SOPs, risk assessments, change controls, CAPA’s and other documentation related to biologics manufacturing.
• Support Regulatory and Compliance Inspections at the site, as required.
• Support the wider quality team in areas of supplier quality management, quality agreements, new product introduction, deviation management, change control management, master data management and complaint management.
• Ensure the health & well-being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.
• Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Drive continuous improvement and participate in 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:

• Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
• At least 3 years’ experience in the pharmaceutical industry (preferably experience in Biologics).
• Understanding and practical application of GMP standards and regulations.
• Working knowledge of QMS regulations and best practices.
• Desire to continuously learn, improve and develop.
• Analytical problem-solving skills.
• Experience supporting Documentation Management Systems.
• Experience with Deviation Writing.
• SAP Master Data experience would be an advantage.

Required Skills:

Accountability, Accountability, Adaptability, Analytical Thinking, Aseptic Manufacturing, cGMP Compliance, Complaint Management, Data Analysis, Decision Making, Documentation Review, FDA Regulations, GMP Compliance, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Legal Compliance, Manufacturing Compliance, Pharmaceutical Management, Production Operations, Quality Assurance (QA), Quality Inspections, Quality Management, Quality Management System Auditing, Quality Management System Improvement {+ 5 more}

Preferred Skills:

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/7/2026

*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.