Quality Assurance Release Specialist - Days

Description Overview

The Quality Assurance Release Specialist is responsible for ensuring final compliance to food safety and quality standards prior to batch disposition.  
 

The primary compliance requirements of this position include:

• The review of batch records, 
• Coordination and execution of batch disposition, 
• The administration of the Net Content’s system, 
• Training and coaching to Good Documentation, 
• Effective implementation of quality standards and Operational Deviation Incident reporting.  
• Participating in risk analysis for production issues, investigations, HACCP and providing audit support when needed.  
• The position supports quality regulations and Perrigo standards in the cost-effective manner.  

Scope of the Role

• Quality Mastership:  Execute positive release for finished product.  Conducting preliminary and final audits of batch records, facilitating paperwork corrections and completions, maintaining communication to supply chain, and preparing batch files for final disposition.  Perform final positive release of all non-exceptional finished product batches.  Administration of the Net Contents system to assure the proper implementation and training of the operators.
  
  Identify non-conformance issues and coordinate Food Safety/Quality risk analysis, lead/support investigations, prepare and finalize non-conformances in Intelex and recommend proper disposition of associated product.   
   
• Quality System: Support and update Quality procedures, work instructions and tools.  Support all facility Trace and Mock Recall events. 
   
• Quality Guardianship: Notify appropriate production personnel/management of deviations, non-conformances and blocked product.  Assure investigations and appropriate actions are on track to meet release time.  Perform requests for Change of Status (COS) and for batch return 
  
  Support Business Unit readiness for internal and external audits.  Support Management of Change (MOC) implementation as needed.  

Experience Required

• Bachelor's degree or equivalent (preferred microbiology, chemistry, or food science)
• 3+ years laboratory or quality control related experience preferred.

Other Skills:

• Problem-solving skills: ability to make quick accurate decisions.
• Ability to prioritize, multi-task and work in a fast-paced environment.
• Task oriented approach to projects and assignments
• Knowledge of Microsoft Word and Excel required; SAP experience is preferred.
• Ability to work flexible hours