Batch Issuance Specialist
: Job Details :

Job Responsibilities

• Coordinates the issuance of batch records with MBR revisions and change control closures.
• Coordinates issuance of batch records with QA Holds by working with Supply Chain personnel to ensure records are issued appropriately.
• Creates the electronic and hardcopy file folders for each batch file.
• Prepares and prints the batch production record from the master production record file.
• Checks the batch production record for accuracy.
• Logs the batch production record issuance information into the batch tracking log.
• Obtains the required forms associated with each stage of manufacturing.
• Sorts and stages the batch production records and forms for autoclaving (as applicable)
• Distributes the prepared batch production record to manufacturing designates.
• Reconciles cancelled batch production records.
• Communicates status of batch production records with the Supply Chain Manager.

Experience Requirements

• Must have experience with Microsoft Office.
• Must be able to read and write English, perform mathematical calculations, follow instructions, attend to details, and have good communication skills.
• Must be able to manage the workload to meet designated timelines.
• Must be able to interact with other in and out of the department in a professional manner.
• Must be able to sit/stand for extended periods of time and climb stairs as needed.
• Must be able to lift 25 lbs.
• Must be able to see and read small print and graduations.

Education Requirements

• Associate's Degree with a minimum of 1 year working in the pharmaceutical manufacturing industry or related healthcare field.