Job Description
A fantastic opportunity has arisen for a
QC Support Associate Specialist,
within the QC department, where you will be responsible for 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.
The role ensures that the QC team objectives are effectively achieved, consistent with Our Company's requirements to ensure compliance, safety and reliable supply to our customers.
What you will do
Bring energy, knowledge, innovation and leadership to carry out the following
* Liaise with logistics and warehouse personnel to communicate incoming samples for testing.
* Maintaining and supporting the Stability Program at the site.
* Supporting stability strategies for new and licensed products.
* 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 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.
* Review and approve key stability quality deliverables including GLIMS reports, Change controls, deviations and CAPAs in SAP.
* Ensure that all stability activities comply with cGMP, including acting as auditee designee for CQAC/Regulatory Bodies /third parties site inspection.
* Provide second person review support for team members stability documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.
* Author/revise standard operating procedures and Stability Guidelines.
* Initiate and Manage change controls associated with Stability Program, sample management, methods, changes to processes pertaining to the QC Labs, updates to Specifications.
* 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.
* The scope of this role also includes COMET Quality Data Stewardship, expected to be approximately 20% of the role.
* Responsible for the timely and accurate delivery of SAP Quality Master Data changes to support the site with material master updates, new material introduction, quality information records, inspection plans (with interface to GLIMS) and certificate profiles.
* Actively engage with wider business, site and above-site, to accept demand for SAP Quality Data changes, weekly attendance at site Material Review Board and monthly attendance at QM CoP.
In order to excel in this role, you will need
* Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment
* Experience in QC (Stability and/or sample management an advantage)
* A minimum of 3 to 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
* Prior experience in QC, sample management or Stability processes is advantageous.
* Working knowledge in the biotech industry is required with specific understanding of QC operations, regulatory agency engagement
* 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.
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, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Chemical Analysis, Data Analysis, Karl Fischer Titrations, Laboratory Instrumentation, Laboratory Techniques, Management Process, Microbiology Research, Quality Control Management, Supervision, Teamwork, Technical Transfer, Technical Writing, Ultraviolet Visible Spectroscopy
Preferred Skills
Job Posting End Date
08/16/2025
* A job posting is effective until PM 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
R361713