Quality Assurance Batch Release Assistant - 1st Shift

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Job Summary:

Quality Assistant will perform timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.

Role Responsibilities:

· 0-1 years of experience in a pharmaceutical manufacturing environment.

· Issues batch records in paper or electronic format and ensures accuracy prior to production.

· Issues additional forms and labels as needed.

· Reviews batch records in paper format for accuracy and completeness according to SOPs and cGMPs.

· Ensures all applicable final quality testing has been completed and is approved.

· Identifies deviations from processes and notifies the applicable personnel for the initiation of an investigation.

· Identifies, communicates, and tracks errors.

· Identifies basic supporting evidence that can supplement a documentation correction.

· Assists personnel in completing corrections on their own batches or on other reviewer’s batches.

· Dispositions batches based on the document review and result of any applicable investigations.

· Familiar with SOPs relevant to batch record review and processes being reviewed.