Lead, Inspection Fri-Sun, WAM

Company: Novo Nordisk
Location: Bloomington
Posted on: July 16, 2025

Job Description:

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 positionsAll employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & Disability InsuranceEmployee 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 Shift: WAM Friday -Sunday 6AM-7:30PM This will be the initial shift, but may change in the future due to business needs, so candidates must be flexible for shift changes, including working weekends. Relationships Reports to Manufacturing Supervisor. Essential Functions Room LeadHas developed expertise typically developed through a combination of job-related training and considerable on-the-job experienceTypically acts as a lead, coordinating the work of others – but not a people managerWorks autonomously within established procedures and practicesAssist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistanceTake a leadership role in the investigation of procedural deviations, SOP revisions and non-conformances, working closely with Quality Assurance counterparts to develop and execute robust CAPAsMay lead shift handover or act as a shift lead in the absence of a supervisorMust have in depth understanding and usage of Operational Excellence concepts and toolsAssigns employees responsibilities and tasks to be perform for the dayOperators time management including rotationsEscalate behavioral or non-conformance to SupervisorAdvance Documentation Skills (GMP preferred)Capable of working with minimal supervisor and high-level stressed environmentAbility to work with cross functional departmentsAbility to identify opportunities for improvement such as 5S, waste elimination and non-value-added tasksAbility to lead and perform first line operator functionsAdditional duties may not be limited to the job description and will be up to the Manager to be added as requiredReview all activities within the Master Batch Record (MBR) throughout the shift, at the end of shift and at the end of production to ensure effective and accurate communication of production activities is documented in accordance with standing procedures and ALCOA principles Equipment LeadWorks within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignmentsSafely operates complex equipment in accordance with cGMPsGeneral understanding of batch records and following procedures based off the steps provided in a batch recordTroubleshoot basic equipment and recommend solutionsEfficiently and safely setup and changeover various pieces of production equipment within the departmentEscalate equipment issues in a timely manner to avoid downtimeHas developed expertise typically developed through a combination of job-related training and considerable on-the-job experienceTrains other employees on the equipment within the departmentAble to print reports and correctly diagnose the report for accuracy according to the quantity of the finished productSubmit work orders for complex trouble shooting issues via maintenance request eformAssists the Production Supervisor in staffing fellow Equipment Operators for successful production runsLog detailed equipment issues in an event log that is issued within the batch recordReviews all equipment related activities within the Master Batch Record (MBR) throughout the shift to ensure effective and accurate communication of equipment and production activitiesProvide leadership to manufacturing and equipment personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistanceSends daily shift reports to other shifts with a breakdown of production and equipment issuesLikely to act as an informal resource for colleagues with less experiencePartners with engineering and production supervisors to develop training for peers and implement improvement projectsAssist equipment operators and provide coaching on how to interact with equipment when requiredExpected to fulfill and maintain designated trainer requirements as needed 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. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 35 pounds. Must pass annual vision test. 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 High School/GED requiredAssociate’s degree or higher preferred2 years of direct pharmaceutical manufacturing experience2 years of GMP experienceTechnical RequirementsProficient in Excel, Word, and other office systemsAbility to learn and use quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, LIMS, etc.Ability to understand and apply CGMPs to everyday workDemonstrates advance understanding of the work tasks assignedExecutes procedures with high qualityBasic understanding of pharmaceutical production operationsCapable of learning unfamiliar principles or techniques with trainingContribute to deviation investigations and corrective / preventative actionsAbility to interpret data, analyze trends, and participate in solutionsApplies best practices to work activities Behavioral RequirementsAbility 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 necessaryAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of timeAbility to cooperate with coworkers within an organized team environment or work aloneDetail oriented and well organized with ability to work effectively under high pressure with multiple deadlinesAbility to put aside personal opinions and focus on business needs, department needs or group needs Leadership Requirements (No Direct Reports)Lead by example according to the Company's values and cultureDevelops contacts and builds relationships with peersSeeks to learn from othersTakes initiative when necessary to address changes in scope or procedural errors 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.

Keywords: Novo Nordisk, Muncie , Lead, Inspection Fri-Sun, WAM, Manufacturing , Bloomington, Indiana