Bioanalyst II
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Bioanalyst II
Ref No.: 17-03057
Location: Rocky Mount, North Carolina
Start Date / End Date: 10/10/2017 to 08/06/2018
Batch Release Specialist

The Batch Release Specialist will be responsible for performing review of Biological Quality laboratory data including environmental monitoring and final product data. This individual will ensure that all results are within specification and performed per the applicable test method and that appropriate GMPs were followed. The individual will be the final review prior to release to plant release. 

POSITION RESPONSIBILITIES 


Below is a representation of the kind of responsibilities expected. Other duties not included below are typically required for the job.

1. The Batch Release Specialist functions as a dedicated data reviewer for the Biological Quality Lab. 
2. This position prioritizes data review and testing with guidance from Supervision/Management. 
3. The Batch Release Specialist is to attend review site release meetings. 
4. 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. 
5. This individual will be responsible for cancellation of lots in LIMS and running final product reports. 
6. This individual will assist in monitoring laboratory metrics associated with release and turnaround goals.



EDUCATION AND EXPERIENCE 

• 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. 

TECHNICAL SKILLS REQUIREMENTS

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

PHYSICAL POSITION REQUIREMENTS 

• 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.