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Manufacturing Specialist

Job description

Responsibilities:

  • The Manufacturing Specialist will be primarily responsible for resolving fill/finish nonconformances (NCs)
  • Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
  • Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
  • Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
  • Assisting as needed in audit by external agencies in answering questions related to NCs
  • Performing other duties as required by Manufacturing Management Basic

Qualifications:

  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions
  • Experience interacting with representatives of regulatory agencies

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