Job Title: QA / RA Compliance Specialist

Location: St. Petersburg, FL

Schedule / Hours: Monday - Friday, 8am - 5pm or 9am - 6pm, onsite

Type: Temp

Responsibilities

• Preparation and submission of ANDA / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant / site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
• Prepare and submit all federal, state and local permits in timely manner
• Interact with customers and gather information as needed to support registration activities
• Provide regulatory impact assessment on all change controls as required

Requirements

• Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology)
• A minimum of 3 years related experience in the pharmaceutical manufacturing industry
• Strong background working with Change Controls and management of change control processes.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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