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
