QA Specialist I/II/III

Responsibilities:

  • Review of quality and manufacturing deviations and complaints, SOPs, and change control documents
  • Assist with investigations and audits
  • Ensure cGMP compliance at all times
  • Reporting of investigations, deviations, and audits
  • Writes and reviews SOPs
  • Reviews data to determine trends
  • Manages and ensures timely completion of CAPA commitments
  • Implements Change controls
  • Generate and report complaint metrics for meetings and Annual Product Reviews
  • Complaint handling
  • Develop Monthly reports
  • Responsible for filing, scanning, faxing FDA regulated documents

Requirements:

  • Bachelor’s degree highly desired
  • 2 years of experience as a QA Specialist within cGMP regulated industry
  • Pharmaceutical, nutraceutical, food/beverage, medical device industry or related experience is preferred
  • Experience with CAPA, Investigations, and deviations is a plus
  • Experience writing and reviewing SOPs
  • Strong written and verbal English communication skills
  • Strong knowledge of Microsoft office (Excel/Word)

EOE/ADA

Job Type: Full-time

Experience:

  • GMP/cGMP: 2 years (Required)
  • Pharmaceutical: 2 years (Required)
  • Quality Assurance: 2 years (Preferred)

Education:

  • Bachelor's (Preferred)

Location:

  • Tampa, FL (Required)

Work authorization:

  • United States (Required)