Job Description

Excellent opportunities exist within Carlow QC for Quality Control Specialist Team Leads supporting extended day shifts.

What you will do:

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

Support new product introductions and provide quality expertise during product release.

Generate, review, approve, and expedite QC GMP documentation, including Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, SOPs, SWIs, change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit (OOPCL) events, and Compendial Assessments.

Author and provide technical oversight for investigations, quality notifications, and related documentation.

Ensure compliance with the company’s global policies, regulatory requirements, and current Good Manufacturing Practices (cGMP) to maintain safety, quality, and reliable supply.

Support Quality Control laboratory activities through documentation, investigations, filing, tracking, auditing, and database maintenance.

Lead and support batch release activities by completing timely investigations, quality notifications, OOPCL events, and generating interim/summary reports.

Raise and investigate CAPAs and quality notifications using standard problem-solving tools (FMEA, Fishbone diagrams, 5 Whys), and implement corrective actions via change management.

Maintain data integrity principles (Attributable, Legible, Contemporaneous, Original).

Act as a document system expert: review, approve, format, and facilitate documentation workflows.

Participate in internal and external audits, ensuring departmental compliance and readiness.

Provide coaching, mentoring, and guidance to laboratory teams and colleagues with less experience.

Lead or support projects and promote teamwork, open communication, and a high-performing, inclusive culture.

Collaborate cross-functionally to ensure manufacturing, testing, and release processes comply with cGMP and regulatory standards.

Support qualification/validation, technical transfers, and commercial operations with quality oversight.

Perform laboratory testing and material inspections according to approved methods, including analytical, microbiological, environmental monitoring, and stability testing.

Detect, report, investigate, and close out out-of-specification (OOS) and out-of-trend (OOT) results.

Manage and monitor Quality Management Systems, generate performance and quality event reports.

Approve QC SOPs and change controls to ensure system compliance with the company’s Quality Management System (QMS).

Ensure compliance with change management processes and assess impacts of changes.

Provide quality support for supplier/material qualification, validation, risk management, and quality agreements.

Develop, revise, and roll out operational procedures and training materials.

Work shift patterns as needed to support manufacturing and quality operations.

What skills you will need:

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

Bachelor’s degree or higher in Analytical Chemistry, Biochemistry, Biology, or a related discipline preferred.

5+ years’ experience in a pharmaceutical laboratory, ideally in a similar role.

Strong technical knowledge and scientific qualification relevant to the pharmaceutical environment.

Good working knowledge of HPLC systems, bioassay methods, and associated software is desirable.

Experience with cGMP, GLP, Quality Management Systems, method validation, and method transfer.

Proficient in QC systems such as EN, LIMS, Trackwise, and Microsoft Office.

Knowledge of Irish, European, and international regulatory codes and standards.

Demonstrated continuous professional development.

Excellent troubleshooting, analytical, and problem-solving skills.

Strong organizational, time management, and multi-tasking abilities.

Effective verbal and written communication skills with strong influencing capability.

Attention to detail, logical thinking, and proactive approach.

Ability to work independently and collaboratively within a team.

Flexible, self-motivated, and adaptable to changing priorities.

Commitment to maintaining a safe, compliant, and quality-focused culture.

At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The 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 a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

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:

Driving Continuous Improvement, GMP Compliance, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Quality Control Management, Supervision, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment

 Preferred Skills:

Job Posting End Date:

08/10/2025

*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:R357867