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Quality Assurance Senior Associate

Louisville, KY
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
  • Self starter
  • Attention to detail
  • Good written and oral communication
  • Regulated environment experience/ understanding of regulations **

Day to Day Responsibilities:    
  • Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
  • Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
  • Perform routine Quality Assurance assessments of site operations and provide direct oversight.
  • Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
  • Represent the Quality Unit during audits and inspections as needed.
  • Support internal/external audits and inspections as part of the audit/inspection team as needed.
  • Perform additional duties as specified by management

"This posting is for Contingent Worker, not an FTE"

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