Quality Assurance, Regulatory Assurance Compliance Specialist

Catalent Pharma Solutions • St. Petersburg, FL

2d • Onsite

About The Position

Quality Assurance, Regulatory Assurance Compliance Specialist Position Summary Work Schedule: Standard Hours; Monday through Friday 100% on-site Join Catalent’s flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. The Quality Assurance, Regulatory Assurance Compliance Specialist plays a key role in supporting Catalent Pharma Solutions and offers a unique opportunity to be deeply embedded across operations, partnering with manufacturing, engineering, product development, and other key functions to drive compliance and regulatory excellence. In this role, you’ll support critical submissions to agencies including the FDA and other global regulators, ensuring that all customer filings accurately reflect on‑site implementation. Catalent also offers exceptional growth potential—providing exposure to change control, investigations, and nearly every facet of quality and regulatory, making this one of the most dynamic and rewarding career paths in the industry. The Role Lead and support complaint investigations in accordance with site SOPs and regulatory requirements, performing structured root cause analysis (5-Why, Fishbone/6M) and assessing product quality, patient risk, and regulatory impact. Ensure investigations are scientifically sound, well‑documented, and include appropriate conclusions, CAPAs, effectiveness checks, and identification of trends or opportunities for product and process improvement. Author, compile, and support Annual Product Reviews (APRs), including collection, analysis, and trending of quality data (complaints, deviations, change controls, CAPAs, OOS/OOT, yields, process performance metrics). Review, coordinate, track, and trend change controls for quality, regulatory, GMP impact, ensuring risk assessments are performed and all actions are appropriately completed, including regulatory impact assessments when required. Prepare and submit A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports), DMFs, site master files, licenses, permits, and registrations to meet FDA and state requirements (especially Florida). Liaise with customers to gather information for registration activities, ensure customer requirements are satisfied, and assist with SOP preparation, review, and approval related to regulatory functions. Assist in regulatory and health authority audits by collecting information as requested and collaborate with SMEs, management, and supervisory personnel to resolve issues affecting product quality, including investigation and CAPA initiation. Other duties as assigned. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Requirements

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology) required.
• 3+ years related experience in the pharmaceutical manufacturing industry required.
• Strong background working with Complaint Investigations, Annual Product Revies, Change Controls and management of change control processes and prior Quality Assurance experience is required.
• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 lbs; no lifting greater than 44.09 pounds without assistance.

Responsibilities

• Lead and support complaint investigations in accordance with site SOPs and regulatory requirements, performing structured root cause analysis (5-Why, Fishbone/6M) and assessing product quality, patient risk, and regulatory impact.
• Ensure investigations are scientifically sound, well‑documented, and include appropriate conclusions, CAPAs, effectiveness checks, and identification of trends or opportunities for product and process improvement.
• Author, compile, and support Annual Product Reviews (APRs), including collection, analysis, and trending of quality data (complaints, deviations, change controls, CAPAs, OOS/OOT, yields, process performance metrics).
• Review, coordinate, track, and trend change controls for quality, regulatory, GMP impact, ensuring risk assessments are performed and all actions are appropriately completed, including regulatory impact assessments when required.
• Prepare and submit A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports), DMFs, site master files, licenses, permits, and registrations to meet FDA and state requirements (especially Florida).
• Liaise with customers to gather information for registration activities, ensure customer requirements are satisfied, and assist with SOP preparation, review, and approval related to regulatory functions.
• Assist in regulatory and health authority audits by collecting information as requested and collaborate with SMEs, management, and supervisory personnel to resolve issues affecting product quality, including investigation and CAPA initiation.
• Other duties as assigned.

Benefits

• Tuition reimbursement to support educational goals
• WellHub program to promote physical wellness & Access to Perkspot discounts from over 900 merchants
• 152 hours of PTO plus 8 paid holidays
• Medical, dental, and vision benefits effective day one
• Defined career path with annual performance reviews & strong potential for career growth within a mission-driven organization
• Inclusive culture with active Employee Resource Groups & Community engagement and green initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level