QA Batch Release Assistant

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

information, please see: https://www.kansasworks.com/jobs/13547959

The Batch Release Assistant will perform a 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.

**Key Responsibilities**

• Reviews all batch documentation for accuracy and completeness
  
  

according to cGMPs to ensure timely release of batches.

• Execute batch record review and review of supporting systems, to
  
  

include LUMAC review

• Adheres to internal/external guidelines, specifications and
  
  

regulatory requirements while reviewing batch documentation.

• Ensures all GMPs, Work Procedures and SOPs are followed.
• Identify exceptions and report exceptions to production.
• Ensures deviations are initiated for any batch record review related
  
  

events Find/communicate deviations to appropriate department for

investigation.

• Effectively resolve documentation discrepancies and issues with
  
  

manufacturing operations personnel in a timely manner to allow for

material release.

• Addresses deficiencies and ensures timely completion of all
  
  

follow-up actions for resolution to all batch review issues

according to GMP standards.

• Responsible for final batch disposition based on review of all
  
  

associated documentation.

• Assist in resolving quality problems/concerns related to batch
  
  

review

• Work proactively on a daily basis to ensure schedules are maintained
  
  

and material is readily available.

• Build quality into all aspect of the material release process by
  
  

maintaining compliance to all quality requirements