Quality - Batch Release Training Specialist

About the job

Candidate will work as a Batch Release Specialist to perform training to new BR Assistants and provide training to new employees.  BR Specialist will also support the timely and efficient GDP, cGMP, and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as trainer, 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. 

Responsibilities

• 2-3 years of experience as a Batch Release Assistant or 2 years of batch release experience plus 1+ years of relevant industry experience.
• Trains new employees on batch issuance and batch review tasks.
• Leads collaboration on paper batch record training SOPs and TCPs.
• Provides training for Good Documentation Practices for new hires or re-training.
• 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.
• Is proficient in the review of controlled substance batch records.
• Reviews electronic batch records.
• Has the ability to handle a heavier batch review load.
• 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.
• Initiates deviations relevant to the batch release department processes.
• 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.
• Identifies and communicates trends in errors and considers the root cause.
• Dispositions batches based on the document review and result of any applicable investigations.
• Knowledge of cGMP requirements and SOPs relevant to batch record review and processes being reviewed.
• Knowledge of FDA guidance and cGMPs.
• Suggests changes in documentation processes.