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Associate Scientist

Patel Consultants Corp

This is a Contract position in Summit, NJ posted July 23, 2020.

The Associate Scientist for QC Sample Management works with supervision and is responsible for the movement of samples and materials in support of the CAR T Quality Control laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, maintaining chain of custody and sample tracking. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs) and aseptic techniques. This position will work weekends, or weekdays and some Holidays to support a 7 day a week operation. Shifts are generally 4 days a week, 10 hours per day Sunday to Wednesday or Wednesday to Saturday. 2. Required Competencies Knowledge, Skills, and Abilities bull Experience with sample storage and transfers bull Ability to work on weekends or weekdays with flexible shift hours bull Experience with LIMS sample management system or equivalent is helpful bull Experience with WORD, PowerPoint, Excel is helpful bull Ability to do appropriate gowning and work in classified cleanroom environment bull Ability to work in a collaborative team environment bull Prior experience and ability to follow and apply Global Regulatory and cGMP requirements bull Ability to adapt and adjust to changing priorities and to meet deadlines bull Ability to follow, review and revise SOPs 3. Duties and Responsibilities bull Responsible for movement of QC biological test samples including receipt, storage, distribution, transfer and disposal bull Maintain sample tracking and chain of custody records in accordance with cGMP requirements and written procedures bull Ensure that expired samplesmaterials are destroyeddisposed of according to written procedures bull Performs sample queries and periodic storage reports as required bull Assist management with investigations and deviations related to sample management bull Collaborate with teams to identify and implement process improvements bull Support sample management metrics bull Facilitate cold chain sample transfers as required QC Lab Inventory bull Assist with maintaining inventory of lab supplies, reagents, media, consumables, etc. bull Liaise with supply chain, warehouse and lab services to ensure supply stocks bull Ensure that materials are appropriately labelled and traceable as per appropriate cGMP, regulatory requirements, and written procedures bull Assist management with investigations and deviations related to lab inventory bull Maintain 5S and FIFO principles as appropriate 4. Education and Experience bull Bachelorrsquos Degree required preferably in a Science related field bull 2+ years of relevant work experience preferably in a regulated cGMP environment bull An equivalent combination of education and experience may substitute