Sr. Tech, Quality Control

Job Description

A fantastic opportunity has arisen for a Sample Management Analyst.

The Sample Management Analyst is responsible for overseeing the receipt, tracking, storage, and disposal of samples within the Quality Control (QC) Laboratory. This role ensures compliance with our standards and regulatory requirements, maintaining the integrity and traceability of samples throughout their lifecycle.

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

• Receive samples from various departments and external sources.
• Supporting stability strategies for new and licensed products.
• Maintaining and supporting the Stability Program at the site.
• Reviewing and approving stability data to support the assigned expiries and labelled storage statements.
• Ensures that all stability activities comply with cGMP, including acting as auditee designee for CQAC/Regulatory Bodies /third parties site inspection.
• Provides second person review support for team members stability documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.
• Initiate and Manage change controls associated with Stability Program, sample management etc.
• Accurately log samples into the laboratory information management system (LIMS) and maintain detailed records.
• Moving lab samples internally around the building from warehouse to labs and vice versa.
• Pulling samples at required timepoints per stability protocol and submitting to the labs for testing.
• Updates Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements when required.
• Initiate and Manage Deviations associated with Stability program, testing, processes etc.
• Assist with Implementation of standard work, visual management, problem solving etc.
• Assist with implementation of Quality Chapters related to QC Topic Owners.
• Engage and Liaise with the appropriate 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.
• Monitor sample inventory levels and initiate reordering of supplies as necessary.
• Conduct regular audits of sample storage areas to ensure compliance with our standards.
• Work closely with QC analysts, laboratory management, and other departments to facilitate sample testing and reporting.
• Provide training and support to laboratory staff on sample management procedures.

What skills you will need:

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

• Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment.
• A minimum of 1-3 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations.
• Strong attention to detail with the ability to manage a complex scheduling activity to keep the group on track for sample management and stability.
• 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.
• Word/PowerPoint/Visio/Excel to create schedules, documents and presentations.
• Demonstrated ability to manage multiple priorities against ambitious timelines.

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.

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.

Required Skills:

Accountability, Accountability, Analytical Method Development, Analytical Method Transfer, Animal Husbandry, Applied Engineering, Bioburden Testing, Business Integrity, Change Control Processes, Chemical Analysis, Detail-Oriented, ELISA Techniques, Environmental Monitoring, Laboratory Informatics, Laboratory Information Management System (LIMS), Microbial Assays, Microbiological Analysis, Pharmaceutical Quality Control (QC), Process Improvements, Project Implementations, Quality Control Management, Quality Management, Sample Management, Sample Testing, SAP Enterprise Resource Planning (ERP) {+ 5 more}

Preferred Skills:

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:

04/25/2026

*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.