Catalent, Inc. is seeking a Quality Assurance & Regulatory Affairs Compliance Specialist to address quality and regulatory compliance challenges at their St. Petersburg, FL facility, ensuring adherence to FDA and state regulations while supporting the development and manufacturing of life-enhancing pharmaceutical products.
Requirements
- Strong background working with Change Controls and management of change control processes required.
- Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred).
- PathWise Certification preferred.
- Ability to solve problems with little guidance.
- Ability to identify the most efficient method to achieve predetermined objective.
- Ability to work effectively under pressure with constantly changing priorities and deadlines.
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 a timely manner.
- 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.
- 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.
Other
- 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 required.
- Ability to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance.
- Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
- Ability to work extended hours or off-hours as required.
