QA / RA Compliance Specialist

Company: Joul--
Location: Saint Petersburg
Posted on: February 4, 2025

Job Description:

Job Title: QA / RA Compliance Specialist

Before applying for this role, please read the following information about this opportunity found below.
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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Keywords: Joul--, Brandon , QA / RA Compliance Specialist, Other , Saint Petersburg, Florida