DURATION - 6 MONTHS EXTENSION POSSIBLE
SHIFT - MON - FRI 8AM - 5PM OR 9AM - 6PM
III. Specific Activities, and Responsibilities:

• Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
• Provide initial regulatory impact assessment on all change controls as required.
• Liaise with customers to ensure customer requirements are satisfied.
• Preparation and submission of A/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
• 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
• Prepare APRs in accordance with site procedures and timelines.
• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
• May author other types of quality system documents as directed or assigned by QA management.

Job Type: Contract

Salary: $30.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• investigation: 3 years (Preferred)
• CAPA, cGMPs, and FDA: 3 years (Preferred)

Work Location: In person