Quality Electronic Training Specialist

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13551323

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.

**Key Responsibilities**

• 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 reviewers 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.