Zoetis, Inc
Aseptic QA Specialist
Zoetis, Inc, Atlanta, Georgia, United States, 30383
What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles.We're a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we're excited to become a part of the Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.We are currently searching for an Aseptic QA Specialist to join our team.Position SummaryThe Quality Assurance team supports operations activities 24/7, and guides site compliance to cGMP, procedure, and regulatory expectations. Qualified Aseptic QA Specialist applicants would have expertise in quality and compliance related to aseptic processing and Code of Federal Regulations (CFR). Additional skills of interest include proven ability to lead and train team members, project management and report writing.(Near-term) Responsibilities in a Startup Environment:
In a startup environment, the Aseptic QA Specialist will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. You will also contribute to CQV of a new aseptic processing area and related equipment/processes. You will support the dynamic needs of the startup and ensure the sustainability and scalability of all procedures as the company grows. Additional activities will include supporting site activities to prepare environmental and personnel monitoring, system, and testing in preparation for media fills and engineering runs that lead to stability batches. The successful candidate will need to be flexible to perform activities outside of the standard Quality Assurance requirements to assist other departments during scale up of staffing and processes.Position ResponsibilitiesSupports quality of materials, manufacturing, and products in a cGMP environment.Evaluates analytical data and releases Zoetis bulk and finished products that conform to corporate, customer, and regulatory specifications.Support Quality Systems and Compliance for the site, including but not limited to training, complaint investigations, and system administration and approvals. Provide guidance on internal procedures and practices as they relate to regulatory and corporate requirements.Participates in internal cGMP audits and supports customer and regulatory audits.Evaluates material changes and approves new material qualifications. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.Conducts and reviews deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other cGMP functions. Provides guidance and oversight in identifying root cause and preventative/corrective actions.Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other cGMP documents and programs. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.Partners with operations and technical support on continuous improvement projects.Education and ExperienceB.S. or equivalent (science background preferred) and 5 - 7 years of relevant experience.Fluent with cGMP regulations and demonstrated knowledge in a Quality Operations role.Exceptional Organizational, Communication and Interpersonal skills.Preferred:M.S. or equivalent (science background preferred) and 3 - 5 years of relevant experience.Work experience in and/or supporting an aseptic processing operation.Technical Skills and CompetenciesRequired:Experience with SAP, ETS (Trackwise), and MS SuiteUnderstanding of CAPA systems and DeviationsStrong interpersonal and communication skills; ability to communicate across all levels of the organization.Excellent attention to detail, communication skills, and strong time management skills.Demonstrated ability to pay close attention to detail and accuracy.Ability to analyze data and synthesize to enable tracking and trending of large issues.Ability to manage multiple tasks and projects simultaneously.Ability to work well independently and as a part of a team, and to work effectively with people at all levels within a matrix organization.Willingness to positively embrace change and flexibility in adjusting to changing priorities.Basic Problem-solving skills and should demonstrate basic troubleshooting ability.Preferred:Existing knowledge of cGMP, FDA, USDA, and EMA regulationsProven project and time management experience including technical writing/review of protocols and reportsPhysical Position RequirementsLift materials up to 40lbsAbility to sit, stand and walkAbility to work flexible hours, work weekend and overtime
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In a startup environment, the Aseptic QA Specialist will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. You will also contribute to CQV of a new aseptic processing area and related equipment/processes. You will support the dynamic needs of the startup and ensure the sustainability and scalability of all procedures as the company grows. Additional activities will include supporting site activities to prepare environmental and personnel monitoring, system, and testing in preparation for media fills and engineering runs that lead to stability batches. The successful candidate will need to be flexible to perform activities outside of the standard Quality Assurance requirements to assist other departments during scale up of staffing and processes.Position ResponsibilitiesSupports quality of materials, manufacturing, and products in a cGMP environment.Evaluates analytical data and releases Zoetis bulk and finished products that conform to corporate, customer, and regulatory specifications.Support Quality Systems and Compliance for the site, including but not limited to training, complaint investigations, and system administration and approvals. Provide guidance on internal procedures and practices as they relate to regulatory and corporate requirements.Participates in internal cGMP audits and supports customer and regulatory audits.Evaluates material changes and approves new material qualifications. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.Conducts and reviews deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other cGMP functions. Provides guidance and oversight in identifying root cause and preventative/corrective actions.Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other cGMP documents and programs. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.Partners with operations and technical support on continuous improvement projects.Education and ExperienceB.S. or equivalent (science background preferred) and 5 - 7 years of relevant experience.Fluent with cGMP regulations and demonstrated knowledge in a Quality Operations role.Exceptional Organizational, Communication and Interpersonal skills.Preferred:M.S. or equivalent (science background preferred) and 3 - 5 years of relevant experience.Work experience in and/or supporting an aseptic processing operation.Technical Skills and CompetenciesRequired:Experience with SAP, ETS (Trackwise), and MS SuiteUnderstanding of CAPA systems and DeviationsStrong interpersonal and communication skills; ability to communicate across all levels of the organization.Excellent attention to detail, communication skills, and strong time management skills.Demonstrated ability to pay close attention to detail and accuracy.Ability to analyze data and synthesize to enable tracking and trending of large issues.Ability to manage multiple tasks and projects simultaneously.Ability to work well independently and as a part of a team, and to work effectively with people at all levels within a matrix organization.Willingness to positively embrace change and flexibility in adjusting to changing priorities.Basic Problem-solving skills and should demonstrate basic troubleshooting ability.Preferred:Existing knowledge of cGMP, FDA, USDA, and EMA regulationsProven project and time management experience including technical writing/review of protocols and reportsPhysical Position RequirementsLift materials up to 40lbsAbility to sit, stand and walkAbility to work flexible hours, work weekend and overtime
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