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Laboratory Sample / Material Coordinator - I

Gwynedd, PA 19454

Posted: 01/31/2023 Employment Type: Contract Job Category: Scientific Job Number: 541583 Is job remote?: No Country: United States

Job Description

The Biological Critical Reagents (BCR) hub in North Wales 4 is part of the Global Quality unit of MSD. The BCR Hub must ensure adequate quality systems are in place to support the manufacture, qualification testing, storage, and distribution of Biological Critical Reagents (BCRs) according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.

Main tasks:
• Maintains and Manages Inventory of BCRs and CRMs (including cell banks)
• Prepares Primary packaging
• Prepare compliant shipping documentation
• Deliver the materials to customers on site
• Arrange pick-ups by external shipping partners for customers off site
• Compile and archive all relevant documentation (e.g. Temptale® data) for future reference
• Communicate with internal and external customers, e.g. regarding lead times and pick-up dates
• Cooperate with external shipping partners and act as a representative of the Shipping team
• Participates in CTU Maintenance as needed
• Cooperate with customs and interact with logistic experts in order to improve the shipping process
• Actively participate in tier 1
• Maintains metrics to show shipping on-time in-full delivery (OTIF) and customer service level (CSL)
• Authors SOPs and SOP revisions as necessary

Deviation Management:
• Is trained as QN coordinator
• Handle Deviations (Observations, Incidents and Investigations) in an appropriate and timely manner
• Contributes to / leads root cause investigations
• Define and execute appropriate CAPAs

Continuous Improvement:
• Signal problems/opportunities within the business
• Participate in and/or leads projects to continuously improve processes.
• Use MPS tools to drive continuous improvement

EHS responsibilities:
• Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.

The Associate Specialist - Shipping carries out internal and external temperature-controlled shipments of Critical Raw Materials (CRM) and BCRs under cGMP conditions to internal and external customers. This includes thorough understanding of import/export rules and regulations.
Education: Associate degree/Bachelors Degree with 3-5years of relevant experience in the pharmaceutical industry and cGMP.

Skills & competences:
• Strong knowledge in cGMP and compliance guidelines
• Continuous Learning Attitude and preferable Lean Six Sigma/ Continuous Improvement mindset
• Computer literacy knowledge (e.g. MS Office, GLIMS)
• Strong focus on clients and end-user
• Ability to work under minimum supervision
• Team work oriented
• Flawless Integrity Mindset
• Strong interpersonal and communication skills, oral and written

Note: This is hybrid role (1-2days/onsite) and would require flexibility to work onsite and early morning (7am) from time to time as per business needs. Shift: M-F(8a-5p).

Pay Range: 15-20/hr
Salary will be commensurate with experience
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