Research Associate/ Laboratory Coordinator

Gaithersburg, MD 20878

Posted: 03/26/2019 Industry: Other Area(s) Job Number: 34460

Research Associate/ Laboratory Manager

Supports the operations of a regulated laboratory performing PK and ADA bioanalyses in compliance with GLP / GCP guidelines. Functions as the point person for the procurement and management of laboratory reagents and supplies. Coordinates maintenance of non-computer-based equipment and prepares associated documentation in accordance with GXP.

• Manages the receipt and storage of laboratory reagents and supplies and may supervise others on these tasks.

• Responsible for ensuring reagents and supplies are ordered and stocked to meet needs of development, validation and sample testing of all bioanalytical methods.

• Functions as the point of contact for the transfer of reagents to and from CTL_GB within as well as to external contacts.

• Manages the Reagent Inventory Module of the Clinical Testing Laboratory Information Management System (CTLIMS). Trains others on the use of this module.

• Maintains and updates electronic inventories of reagents.

• Updates reagent freezer maps monthly

• Responsible for coordination and receipt of CTL_GB wash buffer as per SOP

• Responsible for coordination of quarterly pipet calibrations and out-of-tolerance follow ups • Coordinates lab non-computer-based equipment preventative maintenance, calibration and validations to ensure GLP compliance.

• Responsible for receipt and review of daily temperature chamber unit temperature recordings and follow up of excursions as per SOPs

Requirements/Qualifications:

BA, BS in Biological science or Chemistry with a minimum of 2-5 years or MS with 0-2 years of related work experience in an FDA regulated or medical environment.

Working knowledge of GxP documentation requirements and practices.

Must have excellent PC skills, utilizing Microsoft Office products Word, Excel and LIMS.

Experienced in ordering supplies and coordinating across internal and external groups to support laboratory operations.
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