Sr. QA Releaser

　　Position Summary

　　St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.

　　Sr. QA Releaser is responsible for the documentation review of executed batch records and for product release of pharmaceutical products in accordance with Catalent Policies and cGMPs. Responsible for the review/updating of Standard Operating Procedures (SOPs) as they relate to product assurance. The primary tasks performed by this position will involve evaluating the manufacturing operation for compliance to product processing instructions, policies, and standard operating procedures.

　　Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

　　The Role

　　Review Batch Record documentation for compliance to manufacturing instructions against internal and customer specifications.

　　• Review and approval of executed batch records to assure compliance to cGMPs and Catalent policies and procedures

　　nitiate/facilitate/review/approve, as applicable, documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to product quality prior to release.

　　Write and/or revise standard operating procedures (SOPs) for Product Assurance and provide input to manufacturing procedures.

　　Issue the disposition of manufactured product relative to compliance to approved operating instructions and applicable specifications/procedures.

　　Perform batch certification in the electronic inventory/production management system.

　　Actively participate in corrective actions and continuous improvements in regard to all functions at the site.

　　Assist in complying with any other company and /or departmental objectives as directed by QA management.

　　Provide cGMP/functional training to Quality Assurance and Production personnel as needed.

　　Propose, implement and enforce quality improvements.

　　Support product release schedules to minimize product supply disruption.

　　Support product release schedules in accordance with customer commitments and company goals.

　　The Candidate

　　Bachelor’s Degree in Science (Chemistry, Microbiology or Biology) required;

　　A minimum of five years in QA pharma industry; equivalent of experience, training, and/or education will be considered.

　　Prior experience in product release or related field required.

　　Why You Should Join Catalent

　　Competitive medical benefits and 401K

　　19 days of PTO + 8 Paid Holidays

　　Dynamic, fast-paced work environment

　　Opportunity to work on Continuous Improvement Processes

　　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.

　　Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

　　personal initiative. dynamic pace. meaningful work.

　　Visit Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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.

　　Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

　　Important Security Notice to U.S. Job Seekers:

　　Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

　　California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .