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Job Description: POSITION SUMMARY
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.
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.
In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
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.
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
The Batch Release Specialist reports to the Department Manager. This position requires interaction with several departments throughout the facility.
EDUCATION AND EXPERIENCE
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
• 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
Indicate the technical skills required and/or preferred, as applicable.
Knowledge of LIMS, TrackWise, and Microsoft Office programs is desired.
PHYSICAL POSITION REQUIREMENTS
Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc. Please include any hazardous materials or non-standard working environment the contractor will have exposure to which may require additional medical testing and/or apparatus fitting for OSHA compliance.
• 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 Comments visible to MSP and Supplier: Please note the Official Job Title is: Batch Release Specialist
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