QC Support Specialist

Job Description

• Job Description

A fantastic opportunity has arisen for a QC Support Specialist, within the QC department, where 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.

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

What you will do:

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

·Delivers 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.

·Maintaining and managing the Stability Program at the site.

·Authoring stability strategies for new and licensed products,

·Developing, reviewing and approving 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

·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.

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

·Ensures that all stability activities comply with cGMP, including acting as auditee 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.

·Authors or revises standard operating procedures and Stability Guidelines.

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

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 
• Experience in QC (Stability and/or sample management an advantage)  
• A minimum of 5 to 7 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations 

Technical

• 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 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.
• Word/PowerPoint/Visio/Excel to create schedules, documents and presentations.
• 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 dedicated 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.

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 dedicated to flexible working where possible, and therefore 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 or click on the link to find out more about our hybrid working model

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R285722