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Sr. tech, quality control

Merck Gruppe - Msd Sharp & Dohme
Quality controller
Posted: 16 April
Offer description

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.
Key Responsibilities
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.
Required Skills
Degree (or higher) in Science, Engineering or 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.
Additional Skills
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), and other complementary skills.
Benefits
Flexible Work Arrangements: Hybrid
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.
Equal Opportunity Employer Statement
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Job Posting End Date: 04/25/2026
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