Job Description

A fantastic opportunity has arisen for a Technical Specialist, QC Lab Operations in our Dunboyne facility. This individual will provide second person review support for team members stability documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.

Bring Energy, Knowledge, Innovation To Carry Out The Following

• Maintaining and supporting the Stability Program at the site.
• Supporting stability strategies for new and licensed products.
• Moving lab samples internally around the building from warehouse to labs and vice versa
• Assist in developing stability protocols as per the overall stability strategy.
• Pulling samples at required timepoints per stability protocol and submitting to the labs for testing.
• Managing and reconciling Stability Inventory and Managing on GLIMS.
• Designing and/or updating annual stability protocols as per applicable regulatory requirements.
• Reviewing and approving stability data to support the assigned expiries and labelled storage statements.
• Evaluating and reporting stability data on an annual basis and as needed, including statistical analysis as appropriate.
• Updates Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements when required.
• Ensures that all stability activities comply with cGMP, including acting as auditee designee for CQAC/Regulatory Bodies /third parties site inspection.
• Actively engage with wider business, site and above-site, to accept demand for SAP Quality Data changes.
• Assist in maintaining the QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques including personnel and equipment assignment, and the expected sample schedule.
• Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centers – purchased materials, production, environmental monitoring, inventory, and stability monitoring.
• Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.
  
  

What Skills You Will Need

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

• Experience with GLIMS – Global Lab Information Management Systems.
• Project Management experience
• A proven ability to deliver on tight timelines.
• A Higher Science Degree (MSc, PhD) with industry experience.
• 3+ years industry QC experience.
• MPS (Manufacturing Process Stream) experience is a must.
• Knowledge of domestic and international GMP regulations, cGMP’s, policies, performance and budget management.
• Excellent trouble shooting and problem-solving skills.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to think logically and be proactive under pressure
• Proven ability in using a wide variety of lean tools and building capability within teams.
• Excellent written and oral communication skills.
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
• Required to work on their own initiative in addition to working as part of a team.
• Excellent time management & organisational skills
• An understanding of analytical methodology
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc) desirable.
• Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution
  
  

As a company, we are committed to 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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't 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.

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:

05/21/2025

• 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:R346551