Randstad Clinical Operations in Rocky Mount, North Carolina

Clinical Operations

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job details:

  • location:Rocky Mount, NC

  • salary:$26 - $30.61 per hour

  • date posted:Tuesday, October 10, 2017

  • job type:Contract

  • reference:22873

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description

Job Title: Batch Release Specialist

Loc: Rocky Mount, NC

Position Description

The Batch Release Specialist reports to the Department Manager. This position requires interaction with several departments throughout the facility.

  • Knowledge of LIMS, TrackWise, and Microsoft Office programs is desired

  • Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.

  • Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.

Position Responsibilities

  • The Batch Release Specialist functions as a dedicated data reviewer for the Biological Quality Lab.

  • This position prioritizes data review and testing with guidance from Supervision/Management.

  • The Batch Release Specialist is to attend review site release meetings.

  • The Batch Release Specialist is also responsible for obtaining batch records, distributing the batch records to the appropriate laboratories, and updating laboratory batch records if applicable.

  • This individual will be responsible for cancellation of lots in LIMS and running final product reports.

  • This individual will assist in monitoring laboratory metrics associated with release and turnaround goals.

Position Requirements

  • Minimum of 4 - 6 years experience in a pharmaceutical environment and knowledge of a wide variety of microbiological techniques (e.g., BET, antibiotic potency, sterility, etc.) and analytical techniques (e.g., UV, etc.).

  • Knowledge of cGMPs and regulatory requirements inside/ outside of the US.

  • Knowledge of Environmental Monitoring

  • Good communication, organization and computer skills are required.

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance