Quality Control Analyst I, 4557179

To support functions of the Sample Management group as assigned.

Major Accountabilities

Support functions of the QC Sample Management group as assigned, including, one or more of the following:

Assist in response to BAS alarms and documentation in AIM’s system, including root cause determination and resolution

Assist in the coordination and scheduling of all QCSM equipment PM’s and CM’s

Assist in distribution of all samples destined for various QC labs on 24/7 basis (Bulk, CV, FIO, Fill Finish, MF59, EM/UM, TD special projects, etc). Total QCSM throughput averages over 800 samples per month and is forecasted to increase

Support shipping of QC samples

Support sampling activities in a bio safety cabinet

Support for timely and effective investigation of area DR’s

Support inventory control of all retain, reference and reserve samples

Responsible for ordering and inventory control for glassware and sterile supply to the various QC labs

Support entering all required data into LIMS (materials, projects, products, testing)

Specific training requirements to be determined by functional manager depending on activities assigned.

Skills:

0-3 years industry experience in one or more of the following:

GMPdocumentation in a production environment

Conducting and documenting investigations

Use of electronic document management systems

Use of Atlas document management system or equivalent

Sample collection/distribution/testing/shipment

Material receipt/testing

Glass washing activities and restocking of supplies

BS degree in sciences, preferably Biology or Chemistry, or other related scientific field

For more information, please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960