<p>About the Department</p> <p>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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.</p> <p>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.</p> <p>What we offer you:</p> <ul> <li>Leading pay and annual performance bonus for all positions </li><li>All employees enjoy generous paid time off including 14 paid holidays </li><li>Health Insurance, Dental Insurance, Vision Insurance - effective day one </li><li>Guaranteed 8% 401K contribution plus individual company match option </li><li>Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave </li><li>Free access to Novo Nordisk-marketed pharmaceutical products </li><li>Tuition Assistance </li><li>Life & Disability Insurance </li><li>Employee Referral Awards </li></ul> <p>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.</p> <p>The Position</p> <p>Relationships</p> <p>Supervisor</p> <p>Essential Functions</p> <ul> <li> <p>Supplier Management</p> </li><li> <p>Provides support for the introduction of new material and service suppliers</p> </li><li> <p>Assists in the customer and supplier auditing process providing administrative support including information gathering and organization</p> </li><li> <p>Provide quality support to Quality Control, Materials Management Center, and Supply Chain</p> </li><li> <p>Review / Release inspected incoming materials</p> </li><li> <p>Process supplier complaint investigation records and drive CAPA and disposition decisions</p> </li><li> <p>Gather and report area metrics</p> </li><li> <p>Perform supplier risk assessments</p> </li><li> <p>Support maintenance of the approved supplier list</p> </li><li> <p>Compile supplier pre audit data packages</p> </li><li> <p>Support supplier performance monitoring program</p> </li><li> <p>Provide quality oversight of receipt and storage of all bulk drug substance and cell banks</p> </li><li> <p>Assess damaged materials / product within warehouse spaces</p> </li><li> <p>Perform routine Gemba walks of warehouse spaces</p> </li><li> <p>Perform system, cold storage equipment, and material holds as appropriate</p> </li><li> <p>Other duties as assigned</p> </li><li> <p>Quality Systems and Metrics</p> </li><li> <p>Accountable for the Investigation and CAPA Management Systems</p> </li><li> <p>Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems</p> </li><li> <p>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</p> </li><li> <p>Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations</p> </li><li> <p>Files and maintains controlled documents</p> </li><li> <p>Other duties as assigned</p> </li><li> <p>Quality and Compliance</p> </li><li> <p>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</p> </li><li> <p>Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions</p> </li><li> <p>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</p> </li><li> <p>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</p> </li><li> <p>Review and approve responses to audit findings</p> </li><li> <p>Assists in maintaining facility licenses and registrations</p> </li><li> <p>Organizes documentation and facilitates review in support of client regulatory submissions</p> </li><li> <p>Monitors and assesses changes to regulatory guidance and compendial monographs</p> </li><li> <p>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</p> </li><li> <p>Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations</p> </li><li> <p>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</p> </li><li> <p>Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR)</p> </li><li> <p>Maintains statistical tools to meet requirements for system and process monitoring and review</p> </li><li> <p>Maintains a sufficient understanding of the quality systems and operations</p> </li><li> <p>Files and maintains controlled documents</p> </li><li> <p>Other duties as assigned</p> </li><li> <p>Operational Excellence</p> </li><li> <p>Accountable for execution of the QA on the Floor program</p> </li><li> <p>Partner with Manufacturing and other support teams</p> </li><li> <p>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</p> </li><li> <p>Perform Acceptable Quality Limit (AQL) visual inspection of drug product</p> </li><li> <p>Review batch documents</p> </li><li> <p>Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs</p> </li><li> <p>Initiate deviations as required when observed on the floor</p> </li><li> <p>Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 70% of day is spent on the floor</p> </li><li> <p>Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices</p> </li><li> <p>Provides QA support of Client Person in Plant (PIPs)</p> </li><li> <p>Make solid quality decisions with limited oversight</p> </li><li> <p>Identify continuous improvement initiatives</p> </li><li> <p>Participate in site and corporate quality and process improvement initiatives</p> </li><li> <p>Represent perspective as necessary</p> </li><li> <p>Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices</p> </li><li> <p>Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance</p> </li><li> <p>Other duties as assigned</p> </li><li> <p>Product Quality</p> </li><li> <p>Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports</p> </li><li> <p>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</p> </li><li> <p>Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships</p> </li><li> <p>Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements</p> </li><li> <p>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</p> </li><li> <p>Supports execution of QA on the Floor program</p> </li><li> <p>Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms</p> </li></ul> <p>Physical Requirements</p> <p>Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.</p> <p>Qualifications</p> <ul> <li> <p>Education/Experience:</p> </li><li> <p>Bachelor's degree preferred</p> </li><li> <p>2 - 5 years of relevant experience with Bachelor's degree, preffere</p> </li><li> <p>1-year GxP experience or other regulated industry, required</p> </li><li> <p>Must be able to read and understand English-written job instructions and safety requirements</p> </li><li> <p>Technical Requirements:</p> </li><li> <p>Ability to use Excel, Word, and other office systems</p> </li><li> <p>Ability to learn and use quality management software such as TrackWise or ComplianceWire</p> </li><li> <p>Ability to understand and independently apply CGMPs to everyday work</p> </li><li> <p>Demonstrates understanding of the work tasks assigned</p> </li><li> <p>Executes procedures of moderate complexity with high quality</p> </li><li> <p>Intermediate understanding of pharmaceutical laboratory and/or production operations</p> </li><li> <p>Capable of learning unfamiliar principles or techniques with training</p> </li><li> <p>Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor</p> </li><li> <p>Ability to problem solve and execute and monitor corrective actions</p> </li><li> <p>Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions</p> </li><li> <p>Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor</p> </li><li> <p>Seeks best practices for daily work activities</p> </li><li> <p>Behavioral Requirements:</p> </li><li> <p>Ability to see and hear and read and write clear English</p> </li><li> <p>Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner</p> </li><li> <p>Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time</p> </li><li> <p>Ability to cooperate with coworkers within an organized team environment or work alone</p> </li><li> <p>Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines</p> </li><li> <p>Ability to put aside personal opinions and focus on business needs, department needs or group needs</p> </li><li> <p>Ability to transfer knowledge to others via training or mentoring</p> </li><li> <p>Demonstrated ability to guide others thorough communication and learning</p> </li><li> <p>Ability to make decisions which have moderate impact on immediate work unit</p> </li><li> <p>Leadership Requirements:</p> </li><li> <p>Lead by example according to Catalent's values and culture</p> </li><li> <p>Builds on contacts and relationships with peers</p> </li><li> <p>Take initiative for personal and professional development</p> </li><li> <p>Takes initiative when necessary to address changes in scope and procedural errors</p> </li><li> <p>Builds trust and respect for self and department</p> </li></ul> <p>We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.</p> <p>At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.</p> <p>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.</p> <p>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.</p>