Senior Quality Assurance Releaser

About the Site

St. Petersburg is the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities provide diversification and offerings that increase speed to clinic.

Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve development and manufacturing challenges. Our analytical laboratory provides full-service offerings from development of analytical methods to routine QC testing, supporting commercial and development stability studies.

With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to traditional animal-based gelatin softgels, the site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.

About the Role

We have an opportunity for a Senior Quality Assurance Releaser to join our team. In this role, you will review executed batch records for accuracy and compliance with cGMPs and customer specifications. You will approve batch documentation, release pharmaceutical products, and support quality systems and continuous improvement initiatives. This position plays a key role in ensuring timely product release while maintaining the highest quality standards.

Shift: Standard Hours, Monday through Friday
Location: St. Petersburg, FL – 100% Onsite

Responsibilities

• Review executed batch records for accuracy, completeness, and compliance with current Good Manufacturing Practices, manufacturing instructions, and customer specifications.
• Approve batch documentation and release pharmaceutical products in accordance with Catalent quality standards and regulatory requirements.
• Investigate, document, and approve deviations, discrepancies, and nonconformance reports prior to product release.
• Write, revise, and maintain Quality Assurance Standard Operating Procedures and provide input on manufacturing procedures.
• Perform product disposition decisions and batch certification within the electronic inventory and production management system.
• Partner with cross-functional teams to support corrective actions, continuous improvement initiatives, and quality enhancements.
• Provide current Good Manufacturing Practices and quality systems training to Quality Assurance and Production personnel as needed.
• Support product release schedules to ensure timely customer deliveries while maintaining compliance with company policies and quality standards.
• Other duties as assigned.

Requirements

• Bachelor’s Degree in Science (Chemistry, Microbiology, or Biology) required.
• 5+ years in Quality Assurance within the pharmaceutical industry; equivalent experience, training, and/or education will be considered.
• Prior experience in product release or a related field required.
• Prior Quality Assurance experience in executed batch record review and product release is a must.
• Working knowledge of current Good Manufacturing Practices and/or Occupational Safety and Health Administration regulations required.
• Excellent oral and written communication skills.
• Ability to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Be accessible to manufacturing floor and office staff and use required office equipment.
• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Preferred Skills

• Certified Quality Auditor is a plus.

Benefits

• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement initiatives including regularly participating in Beach Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth.
• WellHub program to promote overall physical and mental wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.