Catalent Inc
Senior QA Technical Reviewer
This position is responsible for the overall Quality Assurance review of all technical documents, as they relate to a) process improvement projects; b) all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems; and e) Deviation and complaint investigation reports. Furthermore, this position will participate in the internal audit program as well as customer audits. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This position is 100% on-site at the St. Petersburg site. The Role Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers, and routine production. Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities. Provide QA Technical recommendations based on trend analysis to eliminate future problems. Participates in various project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Reviews and approves technical documents, such as: Technical Protocols and Reports, Process Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports, and Change Control, as it pertains to the above validated/qualified systems. Reviews and approves deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence. Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and regulatory guidelines). Approve documents as designated by QA management. Other duties as assigned. The Candidate Bachelor's degree in Science or Engineering with minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or Manufacturing pharmaceutical operation. Prior experience working with technical review, investigation writing, including root cause analysis and report writing is a must. Proficient to Advance knowledge of Microsoft programs required (Excel, Word, Access, and PowerPoint). Experience with Documentum, TrackWise, and JD Edwards is preferred. Proficient (excellent) English verbal and written communication skills to communicate with all levels of the organization in various functional areas and receive ideas and instructions to/from others within and outside the organization and effectively present information and respond to questions from site management. Ability to work in a cross-functional team environment. Proven ability to multi-task and demonstrate diplomatic skills. Must possess solid technical expertise as it relates to manufacturing processes, decision-making skills, and the ability to solve problems with minimal guidance. Ability to identify root cause of problems and offer solutions, which address causes, rather than symptoms. Working knowledge of cGMPs and/or OSHA regulations required. Ability to work effectively under pressure to meet deadlines. Individual required to sit, stand, walk, and lift 0-15 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. Why You Should Join Catalent Competitive medical benefits and 401K 152 hours 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. Personal initiative. Dynamic pace. Meaningful work.
This position is responsible for the overall Quality Assurance review of all technical documents, as they relate to a) process improvement projects; b) all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems; and e) Deviation and complaint investigation reports. Furthermore, this position will participate in the internal audit program as well as customer audits. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This position is 100% on-site at the St. Petersburg site. The Role Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers, and routine production. Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities. Provide QA Technical recommendations based on trend analysis to eliminate future problems. Participates in various project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Reviews and approves technical documents, such as: Technical Protocols and Reports, Process Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports, and Change Control, as it pertains to the above validated/qualified systems. Reviews and approves deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence. Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and regulatory guidelines). Approve documents as designated by QA management. Other duties as assigned. The Candidate Bachelor's degree in Science or Engineering with minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or Manufacturing pharmaceutical operation. Prior experience working with technical review, investigation writing, including root cause analysis and report writing is a must. Proficient to Advance knowledge of Microsoft programs required (Excel, Word, Access, and PowerPoint). Experience with Documentum, TrackWise, and JD Edwards is preferred. Proficient (excellent) English verbal and written communication skills to communicate with all levels of the organization in various functional areas and receive ideas and instructions to/from others within and outside the organization and effectively present information and respond to questions from site management. Ability to work in a cross-functional team environment. Proven ability to multi-task and demonstrate diplomatic skills. Must possess solid technical expertise as it relates to manufacturing processes, decision-making skills, and the ability to solve problems with minimal guidance. Ability to identify root cause of problems and offer solutions, which address causes, rather than symptoms. Working knowledge of cGMPs and/or OSHA regulations required. Ability to work effectively under pressure to meet deadlines. Individual required to sit, stand, walk, and lift 0-15 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. Why You Should Join Catalent Competitive medical benefits and 401K 152 hours 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. Personal initiative. Dynamic pace. Meaningful work.