Job Description

A fantastic opportunity has arisen for a QC Stability Specialist. In this role, you will be responsible for oversight, management and coordination of the site Stability program and sample management functions. This position carries the remit and accountability to enable the site to meet compliance and regulatory requirements pertaining to Stability and Sample Management.

You will ensure the QC team objectives are effectively achieved, consistent with site requirements ensuring compliance, safety and reliable supply to our customers.

What you will do:

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

· Deliver a robust Quality Management System for site stability program and sample management to support a flexible, collaborative, multi-skilled teamwork environment.

· Liaise with logistics and warehouse personnel to communicate incoming samples for testing.

· Maintain and manage the Stability Program at the site.

· Author stability strategies for new and licensed products,

· Develop, review and approve stability protocols as per the overall stability strategy.

· Monitor Stability program execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans as needed.

· Manage and maintain QC metrics and dashboards related to stability and sample management to report out on Key performance metrics

· Design and update annual stability protocols as per applicable regulatory requirements

· Review and approve stability data to support the assigned expiries and labelled storage statements,

· Evaluate and report on stability data annually and as needed, including statistical analysis as appropriate.

· Update Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements.

· Reviews and approves key stability quality deliverables including GLIMS reports, Change controls, deviations and CAPAs in SAP.

· Responsible for making decisions within guidelines and policies which impact Stability QC projects.

· Initiate and manage change controls associated with Stability Program, sample management QC methods, changes to processes pertaining to the QC Labs, updates to Specifications etc.

· Initiate and manage deviations associated with Stability program, sample management, testing, processes etc

· Assist with Implementation of standardised work, visual management, leaders standard work etc.

· Develop program for QC SMEs for preparation for Regulatory Inspections and develop storyboard for key QC topics and processes including Stability and sample management

· Assist with implementation of Our Company Quality Chapters related to QC Topic Owners and own the QMS Stability topic for the site

· Engage and Liaise with the appropriate Our Company centres of excellence to ensure the very best of Our Company is brought to site to build excellence into our QC systems and processes including Stability program and sample management

· Be an advocate for continuous improvement.

In order to excel in this role, you will need:

· Third Level science qualification in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment

· Minimum of 5 to 7 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations

· Experience in QC (Stability and/or sample management an advantage)

· Strong attention to detail with the ability to manage a complex scheduling activity to keep the group on track for success.

· Strong ability to organise and prioritise work; ability to create and execute contingency and mitigation plans.

· Ability to summarise data and plans into charts, graphs, diagrams, and tables.

· Experience with SAP (or similar ERP system) and LIMS is beneficial.

· Demonstrated ability to manage multiple priorities against ambitious timelines. Strong problem-solving skills and ability to work cross-functionally as critical member of site team

· Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Change Control Management, Data Integrity, Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI), Laboratory Information Management System (LIMS), Laboratory Operations, Lean Management, Logistics Management, Management Process, Mitigation, Nondestructive Testing (NDT), Process Improvements, Quality Control Management, Quality Improvement Programs, Quality Management, Regulatory Compliance, Regulatory Requirements, Sample Management, SAP Enterprise Resource Planning (ERP), Schedule Management, Standard Operating Procedure (SOP) {+ 5 more}

Preferred Skills:

Job Posting End Date:

07/9/2025

*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.