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
• Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
• Assist in regulatory / health authority audits collecting information as requested
• Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution

Requirements

• Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology)
• 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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