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Quality Associate

3 months ago

Weston, United States Masters Speciality Pharma Full time

THIS JOB IS 100% IN OFFICE - NOT A REMOTE JOB


Duties & Responsibilities

  

  1. Able to demonstrate expertise in Quality Systems and distribution process.
  2. Understand and implement GDP regulations, specifically WHO Annex 5, CFR21 parts 210 and 211, USP 1079 and 1083, Florida state law. 
  3. Manage the local Quality Management System (QMS), ensuring continuous improvement principles are embedded and the site is audit ready.
  4. Provide specialized training to staff.
  5. Ensure Deviations, CAPA and Change Controls are managed in a timely manner reporting any issues to the CCO, CDR.
  6. Ensure Quality KPI are up to date.
  7. Identify, author and/or update SOP’s to ensure continued compliance.
  8. Support the customer complaint process and respond to Customer complaints as required.
  9. Support PV activities as required
  10. Understand and support validation activities.
  11. Assist with the Drug Supply Chain Security Act (DSCSA) traceability documentation.
  12. Assist with the custody of controlled drugs for storage and their release back to the warehouse for shipment.
  13. Assist with the handling of product recalls.
  14. Assist with temperature monitoring and recording of the product storage areas.
  15. Undertake other duties assigned by the CCO, CDR.

 

Skills/Qualifications

 

  • Knowledge of regulations, statutes and regulatory processes on the distribution of prescription drug is preferred.
  •  General knowledge of manufacturers, product names (basics) and product presentation.
  •  Knowledge of basic mathematics (arithmetic, algebra).
  •  Skills in operating computer software, including MS Office – (Outlook, Excel, Word), Windows Operating System, Internet, etc.
  •  Skills in written and oral communication.
  •  Skills in performing fast, extensive and effective internet research.
  •  Skills in time management.
  •  Ability in utilizing critical thinking, using logic and reasoning to analyze data, to identify strengths and weaknesses offering alternative solutions, conclusions or approaches to problems.
  •  Ability to organize multiple work assignments, establish priorities and pay close attention to details.
  •  Ability to work well both independently with specified time constraints and as a part of a team.