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Saint Petersburg, Florida, United States
Onsite
Senior Quality Assurance Releaser
St. Petersburg in 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 at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering 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 any 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 the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.
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
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.
Bachelor’s Degree in Science (Chemistry, Microbiology, or Biology) required.
5+ years in Quality Assurance pharmaceutical industry; equivalent experience, training, and/or education will be considered.
Prior experience in product release or related field required.
Prior Quality Assurance experience of the 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 a must.
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 to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Certified Quality Auditor is a plus.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
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 green initiatives including regularly participating in Beach Clean-up.
Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
WellHub program to promote overall physical and mental wellness.
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Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. 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.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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