Lead, Inspection Fri-Sun WPM

Overview Lead, Inspection Fri-Sun WPM role at BioSpace. 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 The Position Shift: WPM Friday - Sunday 6PM-7:30AM. This initial shift may change in the future due to business needs; candidates must be flexible for shift changes, including weekends. Relationships: Reports to Manufacturing Supervisor. Essential Functions Lead and coordinate the work of others within established procedures; typically not a people manager. Assist manufacturing personnel to identify and eliminate waste, implement standard-work, and provide problem solving and solution implementation assistance. Take a leadership role in investigations of procedural deviations, SOP revisions and non-conformances, collaborating with Quality Assurance to develop and execute CAPAs. May lead shift handover or act as shift lead in the absence of a supervisor. Apply Operational Excellence concepts and tools; assign daily tasks; manage operator rotations; escalate non-conformances to Supervisor. Maintain advanced documentation skills (GMP preferred) and work autonomously in a high-stress environment; collaborate with cross-functional departments. Identify opportunities for improvement (e.g., 5S, waste elimination, non-value-added tasks); lead and perform first-line operator functions. Review activity within the Master Batch Record (MBR) to ensure accurate communication of production activities per procedures and ALCOA principles. Operate equipment safely per cGMPs; troubleshoot basic equipment; perform setup/changeover for production equipment; escalate issues to avoid downtime. Provide training on department equipment and print/diagnose reports; submit maintenance work orders; assist in staffing and shift reports; support deviations investigations and training as needed. Physical Requirements Frequent sitting, standing, walking, reading, computer use; occasional stooping, kneeling, bending; frequent lifting up to 10 pounds and occasional up to 35 pounds. Must pass annual vision test. Must comply with EHS responsibilities. Clean room environment as needed. Qualifications High School/GED required Associate’s degree or higher preferred 2 years of direct pharmaceutical manufacturing experience 2 years of GMP experience Technical requirements: Proficient in Excel, Word; able to learn TrackWise, ComplianceWire, JD Edwards, LIMS, etc. Understanding and application of CGMPs; ability to interpret data, analyze trends, and participate in solutions; contribute to deviation investigations and corrective/preventive actions. Behavioral Requirements Effective communication and ability to follow detailed instructions; work well under pressure and meet deadlines Time management and ability to work independently or in a team Detail-oriented, organized, and focused on business and department needs Equality and Accommodation We commit to an inclusive recruitment process and equality of opportunity for all job applicants. Novo Nordisk is an equal opportunity employer. If you need special assistance or an accommodation to apply, please call View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about application status. #J-18808-Ljbffr