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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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 Quality Assurance department is responsible for all aspects of the quality assurance functions. The department’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. Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities. The Position Relationships Reports to: Caleb Buuck Essential Functions + Pulls together and leads, as appropriate, multi-function teams to trouble shoot, identify root cause(s) and inform on the Corrective and Preventative measure for all deviations + Reviews the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company standard and is appropriately classified + Works with the Quality unit to address any discrepancies or concerns with the classification + Complete all assigned tasks including training by the required due date + Required, as appropriate, to seek out and identify, on location, the processes, equipment and any other areas where a problem related event occurred to view and understand first-hand what happened or could happen + Works with the team to clearly identify and communicate the problem statement that can focus the investigation + Effectively work with a team of SME’s to quickly identify the potential scope of an issue and as required escalate to Leadership to ensure proper actions with customers and regulatory agencies, as required, are properly made and managed + Conduct interviews in a logical and information seeking way to help uncover issues and understand the ability to identify required information and/or data to aid in the investigation and interpret and present the information in a manner that established understanding to help drive the root cause and product impact conclusions + Develops the framework for the investigation hypothesis to allow the SME’s and teams to assess, challenge, and provide necessary expertise in driving the root cause down + Identifies first, all possible corrective and preventative measures through the use of engineering solutions and only moves to administrative controls after the cost/benefit and compliance risk are understood and addressed + Completes all investigation information into a comprehensive deviation report in a manner that clearly defines the problem, the facts and evidence (including circumstantial) that drives a strong root cause conclusion, where possible and is linked to clear and actionable CAPA + Provides a summary presentation of the draft investigation to the deviation review-board with the facts and CAPA(s) to obtain Final Quality unit approval + Defines and as appropriate works with the SME’s to develop a CAPA effectiveness plan as required + Follows up as appropriate post investigation or in the event of a repeat deviations to understand the reason and assess the inadequacy of prior analysis and actions + Acts as a mentor to investigators and providing assistance including expertise when needed + Leads and presents at Team Meetings and Huddles + Completes and closes a minimum of 10 Major Deviations per month Physical Requirements 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. 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. Qualifications + Education/Experience: + Bachelor’s degree in STEM discipline + Master’s degree or higher preferred + 5-8 years of experience + 2 years of GMP experience required or regulated industry + Technical Requirements: + Proficient in Excel, Word, and other office systems + Prior work experience with quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards® + Ability to understand and independently apply CGMPs as it relates to clinical and commercial operations + Demonstrates understanding of the work tasks assigned + Executes complex with high quality + Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines + Intermediate understanding of pharmaceutical laboratory and/or production operations + Capable of learning unfamiliar principles or techniques with training + Prior experience leading deviation investigations using root cause analysis tools + Champion change control and corrective / preventative actions + Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions + Ability to lead technical calls and discussions regarding investigations, audits, or other issues + Seeks best practices for daily work activities + Ability to support Risk Assessments, including QCAs and FMEAs + Behavioral Requirements: + Ability to see and hear and read and write clear English + 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 + 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 + Ability to cooperate with coworkers within an organized team environment or work alone + Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines + Ability to put aside personal opinions and focus on business needs, department needs or group needs + Ability to transfer knowledge to others via training or mentoring + Demonstrated ability to guide others thorough communication and learning + Ability to make decisions which have moderate impact on immediate work unit + Strong critical thinking skills – proven problem-solving capabilities + Sense of urgency - looks to drive the investigation to closure and overcome any obstacles + Solution oriented -seeks out the best solutions through a team of SME’s + Clear communicator -drives actions and sets expectations and follows up + Team building skills - gathers and quickly build a team of SME to deliver results quickly with the best outcomes + Listening skills – ability to listen and gather or pull information out of SME’s and others that might not otherwise easily volunteer information + Leadership Requirements: + Leads by example according to Catalent's values and culture + Builds on contacts and relationships with peers + Takes initiative for personal and professional development + Takes initiative when necessary to address changes in scope and procedural errors + Builds trust and respect for self and department We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 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. 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.