Quality Specialist

3 weeks ago

Elkton, United States Astrix Full time

Our esteemed client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an exceptional Quality Specialist to join their dynamic team.


Responsibilities


  • Collaborate with Technical Operations and Operations to support vaccine, biologic, and sterile manufacturing processes effectively.
  • Review and approve investigations, corrective actions, regulatory commitments, change requests, and validation protocols.
  • Provide guidance on deviation identification and initiate necessary actions.
  • Review batch records and documentation for compliance.
  • Facilitate discussions and fulfill information requests during site inspections/audits as Quality representative.
  • Assist in preparing regulatory filings.
  • Write, review, and approve standard operating procedures and instructional documents.
  • Conduct training for new personnel to ensure compliance with departmental procedures.


Requirements

  • Bachelor's degree in a science discipline (biology, chemistry, engineering, etc.) or related field, with at least 2 years of experience in Pharmaceutical, Manufacturing, Maintenance, Military environments, or GMP, OR a Master’s degree with a minimum of 1 year of relevant experience.
  • Experience reviewing Batch Records.
  • Proficiency in deviation management.
  • Experience in vaccine manufacturing.
  • Proficient in MS Office Suite (Word, Outlook, Excel, PowerPoint), SAP, Electronic Batch Record System (MES), and Delta V system.

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