Job Description

An amazing opportunity has arisen for a QA Specialist at our R&D facility in Dunboyne. The QA Specialist is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.

The QA specialist will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The QA specialist will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. The QA specialist will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

What you will do:

Bring your energy, knowledge, and innovation to:

Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project start-up milestones. Participating in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the start-up facility. Complete QA operational duties related to product disposition including the performance of detailed review of eBR prior to QP release. Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture in our R&D facility. Participate in and support risk management activities in line with relevant guidance and best industry practice. Ensures the escalation of compliance risks to management in a timely manner.

What skills you will need:

To excel in this role, you will have:

·        Degree qualification (Science/Quality/Technical). 

·        4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. 

·        Project Manager capability with significant understanding of Operations. 

·        Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME. 

·        Strong written and verbal communication skills. 

·        Ability to think logically and be proactive under pressure. 

·        Ability to work as part of a team and on own initiative in a constructive manner. 

·        Strong attention to detail and precision in preparing and reviewing GMP documentation. 

·        Experience in quality management systems such as Veeva, SAP, PAS-X etc.

·        Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. 

Experience in direct interactions with regulatory agencies during site inspections

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/17/2025

*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.

Requisition ID:R336808