Manufacturing Quality Assistant

Om jobbet

Candidate will work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as on the floor presence to conduct inspections such as AQL and will also verify proper line clearances, visual inspection and documentation is completed accordingly.  Candidate may also be involved in supporting with deviation/CAPA closure. The MQA Assistant can expect every day to be different with changing responsibilities and priorities.

  • Be able to gown for ISO 8 qualified and ability to maintain qualification on a routine basis
  • Support manufacturing process through an on the floor presence for line clearances, resolution of               issues, or elevation.
  • Perform post production audits of the manufacturing process
  • Perform visual inspection AQL of product
  • Properly document findings during audits
  • Assist in answering questions regarding potential discrepencies of defects
  • Author and update SOPs as needed
  • Follow GMP guidelines and adhere to to SOPs and GMP requirements
  • Communicate QA issues to employees and managers in a tactful manner
  • Work on multiple projects at once with changing deadlines and priorities

Din profil

  • Experience working in a regulated environment (GMP)
  • Ability to handle multi-task activities to support production schedule.
  • Have 20/20 vision, correctable with glasses/contacts.
  • Be able to be visual inspect product
  • Ability to be garb qualified and maintain qualification
  • Detail oriented, ability to get along with a variety of different personalities
  • Strong verbal and written communication skills specifically GDP.
  • Ability to Write and review technical reports
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