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Sample Logistics Associate

Summary:
To support QC analytical testing in support of the biologics Bulk Drug Substance (BDS) manufacturing using defined methods in a cGMP compliant laboratory. If trained on QC analytical testing, the individual assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor.
Responsibilities:
+ Performs receipt of raw materials, in-process, non-routine, release and stability of the Bulk Drug Substance (BDS) in a cGMP environment for both commercial and clinical products
+ Manages test reserves, reserves and BDS retains; disposes of samples as per applicable procedures.
+ Performs sample management including sample tracking, aliquot preparation and sample distribution.
+ Support QC-TS (Technical Support) and BDB (Biological Development Building) teams to receive and aliquot samples for technical transfer activities.
+ Communicates issues with sample processing to area management.
+ Provide direct support to lab personnel to trouble shoot sample management issues.
+ Order, inventory and reconcile critical reagents.
+ Prepare samples to be shipped to 2nd and 3rd parties
+ Receive and process shipments/samples from 2nd and 3rd parties
+ Performs Appearance testing on both BDS and DP (Drug Product) samples
+ Performs DP testing (such as reconstitution time, weigh variation, etc).
+ Log in nonroutine LIMS jobs to support qualification testing, investigations and Tech transfer activities.
Qualifications:
+ Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent is required.
+ High aptitude for customer service; customer oriented and customer service experience a plus
+ Some understanding of regulatory standards.
+ Some relevant experience in a biologics QC lab preferred.
This is a second shift position, 4 days x 10 hrs, Wednesday - Saturday 2pm to midnight
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled


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