Quality Assurance Auditor

ITG - Charlotte, NC (30+ days ago)3.7


Job Description: Quality Assurance Auditor

The Quality Assurance Auditor is responsible for ensuring compliance to GMPs, company SOPs, and all written procedures. Review of production and quality control documents, CoAs, investigation reports, CAPAs, and all other production related documentation is a key function of this role. The Quality Assurance Auditor works with multiple departments to establish GMP systems and improve the quality system as needed. This role would also include participation in developing a quality system.

Essential Functions:

  • Review of documentation related to manufacturing/quality control and ensure that work meets or exceeds internal policies/procedures and complies with GMP standards
  • Support internal manufacturing and quality control teams
  • Serve as the Quality Assurance liaison with multiple departments throughout projects in all stages of development, from clinical trials to commercial products
  • Preparation of Quality System SOPs in conjunction with department managers
  • Work with personnel in multiple departments and participate in key meetings
  • Perform gap analysis and develop solutions to address gaps
  • Track and trend product performance
  • Prepare annual reports and other documents as needed for FDA
  • Aid in development and implementation of a document control system
  • Assist and participate in continuous improvement activities
  • Must be willing to work in a facility that manufactures radioactive isotopes

Qualifications:

  • BSc or equivalent plus a minimum of 5 years of experience in pharmaceuticals or radiopharmaceuticals in a quality assurance capacity
  • Proficient in English
  • Excellent communication skills, both verbal and written
  • Able to identify issues and develop solutions to improve quality and efficiency
  • Able to work in a team-based environment with personnel from multiple departments
  • Familiarity with OOS, CAPA, and out of trend investigation reporting
  • Detail oriented
  • Able to adjust work schedule based on company needs
  • Strong work ethic and sense of urgency

Job Type: Full-time

Experience:

  • Quality Assurance: 5 years (Required)
  • pharmaceuticals: 5 years (Required)

Education:

  • Bachelor's (Required)

Location:

  • Charlotte, NC (Required)