divh2Quality Operations Manager/h2pThe Quality Operations Manager is responsible for leading and supporting Quality Operations activities including CAPA management, batch record review and release processes, proactive compliance initiatives, and continuous improvement efforts./ppPosition Summary/ppThis position is 100% on-site at the St. Petersburg site./ppMonday - Friday hours/ppSt. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges./ppThis role will partner closely with Manufacturing, Technical Services, and Quality Leadership to ensure effective investigation execution, documentation quality, timely corrective and preventive action implementation, and ongoing compliance monitoring./ppThe Role/pulliManage complex and high-level proactive compliance initiatives and continuous improvement efforts in collaboration with internal Catalent stakeholders./liliProvide leadership support and oversight to Quality teams responsible for CAPA management and batch record review and release activities./liliProvide lead investigator, reviewer/approver, mentorship/coaching, rapid response, operational excellence analysis, technical writing, preventive action planning, and compliance monitoring systems (e.g., TrackWise) training./liliEnsure site proactive compliance initiative training programs meet regulatory and customer requirements./liliRecommend and drive process improvements based on trend data from CAPAs, complaints, investigations, audits, and quality metrics./liliPerform advanced review of supporting documentation including batch documentation, test results, specifications, training records, SOPs, calibration records, and validation documentation./liliParticipate in site quality initiatives and support Management Review and metric reporting activities./liliOther duties as assigned./li/ulpThe Candidate/pulliBachelors Degree in Science or related field required (Chemistry, Microbiology or Biology); with a minimum of five years related experience in QA pharmaceutical manufacturing./liliPrior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred)./liliQuality Management previous experience in GMP regulated pharmaceutical environment./liliAbility to effectively present information and respond to questions from peers, management, suppliers and customers./liliProficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access). Working knowledge of cGMPs and/or OSHA regulations required. Certified Quality Engineer is a plus./liliAbility to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 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 frequent use of computer monitor./li/ulpWhy You Should Work At Catalent/pulliSpearhead exciting and innovative projects/liliFast-paced, dynamic environment/liliHigh visibility to members at all levels of the organization/lili152 hours of PTO + 8 paid holidays/li/ulpCatalent 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./ppPersonal initiative. Dynamic pace. Meaningful work./ppVisit Catalent Careers to explore career opportunities./ppCatalent is an Equal Opportunity Employer, including disability and veterans./p/div