Randstad Clinical Operations in Rocky Mount, North Carolina
location:Rocky Mount, NC
salary:$26 - $30.61 per hour
date posted:Tuesday, October 10, 2017
Job Title: Batch Release Specialist
Loc: Rocky Mount, NC
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.
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.
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.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance