About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: + Leading pay and annual performance bonus for all positions + All employees enjoy generous paid time off including 14 paid holidays + Health Insurance, Dental Insurance, Vision Insurance – effective day one + Guaranteed 8% 401K contribution plus individual company match option + Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position This role's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients. Relationships Reports to Supervisor. Essential Functions + Supplier Management + Collaborates with Quality Control, Materials Management, Supply Chain and Manufacturing to ensure that materials are available for use + Provides support for the introduction of new material and service suppliers + Support management and assessment of supplier change notifications and material change requirements + Assists in the customer and supplier auditing process providing administrative support including information gathering and organization + Provide quality support to Quality Control, Materials Management Center, and Supply Chain + Review / Approve all incoming Material Specification Sheets + Review / Release all inspected incoming materials + Act as subject matter expert to internal and external customers regarding supplier qualification, material receipt / inspection / release and storage requirements + Review and approve supply quality related records (e.g. deviations change controls, etc.) to ensure compliance to regulatory and procedural requirements is maintained + Process supplier complaint investigation records and drive CAPA and disposition decisions + Gather and report area metrics + Perform supplier risk assessments + Support maintenance of the approved supplier list + Compile supplier pre audit data packages + Support supplier performance monitoring program + Provide quality oversight of receipt and storage of all bulk drug substance and cell banks + Assess damaged materials / product within warehouse spaces + Perform routine Gemba walks of warehouse spaces + Perform system, cold storage equipment, and material holds as appropriate + Other duties as assigned + Quality Systems and Metrics + Accountable for the Investigation and CAPA Management Systems + Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal stakeholders to support the effective execution of the Investigation and CAPA systems + Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes + Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations + Files and maintains controlled documents + Other duties as assigned + Quality and Compliance + Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders + Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions + Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors + Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions while onsite + Review and approve responses to audit findings + Assists in maintaining facility licenses and registrations + Organizes documentation and facilitates review in support of client regulatory submissions + Monitors and assesses changes to regulatory guidance and compendial monographs + Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes + Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations + Supports the management of customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements + Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR) + Maintains statistical tools to meet requirements for system and process monitoring and review + Maintains a sufficient understanding of the quality systems and operations + File and maintain controlled documents + Other duties as assigned + On-Floor Support (DP and DS) + Accountable for execution of the QA on the Floor program + Partner with Manufacturing and other support teams + Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing + Review batch documents + Review and disposition of media/buffer formulation batches + Assist with revision of GMP documentation such as Standard Operating Procedures + Initiate incident description forms and/or deviations as required when observed on the floor + Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, formulation of media/buffer, and manufacture of bulk drug substance– 70% of day is spent on the floor + Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices + Provides QA support of Client Person in Plant (PIPs) + Make solid quality decisions with limited oversight escalating all process-stopping issues to area management and quality management + Acts as QA reviewer on Minor deviations + Identify continuous improvement initiatives + Participate in site and corporate quality and process improvement initiatives + Represent perspective as necessary + Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices + Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance + Assists and train colleagues on aseptic behavior, techniques, and best practices + Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite + Provide immediate feedback during routine observation to line leaders and colleagues, both positive practices and opportunities for improvement to allow for further development of colleague capabilities + Observe, coach and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impact processing + Analyze, develop, and improve quality systems and associated business processes to achieve compliance with global regulatory requirements + Perform investigations using root cause analysis tools and work with impacted areas on CAPAs to address root cause + Support investigation activities utilizing root-cause and problem-solving methodologies, including support of CAPA development and implementation + Develop and maintain department and site metrics for monitoring critical process and Quality attributes + Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects + Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment + Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner + Follow all SOPs, cGMPs, batch records, and remain current with all training requirements + Other duties as assigned + Product Quality + Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports + Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations + Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships + Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements + Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems + Supports execution of QA on the Floor program + Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms + Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance + Other duties as assigned + Batch Review/Disposition (DP and DS) + Reviews executed batch records + Dispositions product with delegation + Ensures all in-process specifications are met + Ensures all corrections found are made to batch records + Interacts with clients in a professional manner to ensure timely resolution of post-disposition corrections + Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements. + Maintain a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems. + Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. + Other duties as assigned. Physical Requirements 100% onsite at the Bloomington, Indiana site. Qualifications + Bachelor's degree and 2+ years of experience or Master's degree and 0+ years of experience required + Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred + A strong working knowledge of quality systems and processes, preferred + GxP experience or other regulated industry, required + Technical Requirements + Ability to use Excel, Word, and other office systems required + Ability to learn and use quality management software such as TrackWise® or ComplianceWire® required + Ability to understand and independently apply CGMPs to everyday work required + Intermediate understanding of pharmaceutical laboratory and/or production operations required + Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor required  + Ability to problem solve and execute and monitor corrective actions required + Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions required + Must be able to read and understand English-written job instructions and safety requirements required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.