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.

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

Job Type: Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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