Quality Assurance Officer

Sobre el puesto

We are seeking a Quality Assurance Officer to join our Quality Team.  The position is responsible for the following

  • Review batch records for the purpose of determining compliance and correctness
  • Write and revise standard operating procedures to ensure continued compliance with cGMP
  • Organize and update site operations manual
  • Review and maintain training records for site
  • Assist with regulatory recordkeeping, inventory reconciliation, submissions, and registrations
  • Review, organize, and submit quality and compliance documents for our global quality system
  • Support audits and regulatory inspections
  • Review various quality systems to evaluate for patterns or trends, and to offer suggestions for improvement
  • Continuously inform yourself about the latest regulatory trends, and recommend specific actions or focus in order to further the strategy of the organization
  • Perform internal audits for the purpose of determining compliance with existing procedures, or areas for improvement of existing procedures
  • Review regulatory product statements for the purpose of drafting customer responses. Submit these responses for review/approval, and support customers as a result
  • Read FDA and other compliance documents for the purpose of providing input and direction for the quality unit

Destáquese del resto

You possess the following qualifications, background and abilities:

  • Minimum of High School diploma required, bachelors or professional degree preferred
  • Must have good computer skills, Microsoft office and others
  • Job experience or demonstrated ability to perform meticulous work with very low error rates
  • FDA and/or DEA experience desired, but not necessary, other regulated industry experience will also be useful
  • Experience working in regulated industries or highly structured environments required
  • Ability to maintain multiple priorities, both routine and project based. Project must be completed on-time, or challenges communicated to manager
  • Strong communication skills
  • Ability to work collaboratively or alone to accomplish department objectives
  • Ability to quickly adapt to changes

Qué ofrecemos

Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.

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