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Laboratory Sample / Material Coordinator - I

North Wales, PA

Posted: 01/18/2023 Job Number: 22886884

Job Description

LABORATORY SAMPLE / MATERIAL COORDINATOR I
NORTH WALES, PA
Hybrid role.

Required Skills:
  • Associate degree/bachelor's degree with 3-5years of relevant experience in the pharmaceutical industry and cGMP.
  • Strong knowledge of 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-users.
  • Ability to work under minimum supervision.
  • Teamwork oriented.
  • Flawless Integrity Mindset.
  • Strong interpersonal and communication skills, oral and written.

Project Description:
  • 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 a thorough understanding of import/export rules and regulations.
  • 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.
  • 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 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.

This 11+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Supriya: supriya@AlphaConsulting.Com

ALPHA'S REQUIREMENT #23-00149
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Supriya Kamble

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