Lead, Inspection Sun-Fri 11 PM - 7:30 AM

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

Work shift: Sunday - Friday 11 PM - 7:30 AM

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 experience

Typically acts as a lead, coordinating the work of others – but not a people manager

Works autonomously within established procedures and practices

Assist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance

Take 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 CAPAs

May lead shift handover or act as a shift lead in the absence of a supervisor

Must have in depth understanding and usage of Operational Excellence concepts and tools

Assigns employees responsibilities and tasks to be perform for the day

Operators time management including rotations

Escalate behavioral or non-conformance to Supervisor

Advance Documentation Skills (GMP preferred)

Capable of working with minimal supervisor and high-level stressed environment

Ability to work with cross functional departments

Ability to identify opportunities for improvement such as 5S, waste elimination and non-value-added tasks

Ability to lead and perform first line operator functions

Additional duties may not be limited to the job description and will be up to the Manager to be added as required

Review 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 assignments

Safely operates complex equipment in accordance with cGMPs

General understanding of batch records and following procedures based off the steps provided in a batch record

Troubleshoot basic equipment and recommend solutions

Efficiently and safely setup and changeover various pieces of production equipment within the department

Escalate equipment issues in a timely manner to avoid downtime

Has developed expertise typically developed through a combination of job-related training and considerable on-the-job experience

Trains other employees on the equipment within the department

Able to print reports and correctly diagnose the report for accuracy according to the quantity of the finished product

Submit work orders for complex trouble shooting issues via maintenance request eform

Assists the Production Supervisor in staffing fellow Equipment Operators for successful production runs

Log detailed equipment issues in an event log that is issued within the batch record

Reviews all equipment related activities within the Master Batch Record (MBR) throughout the shift to ensure effective and accurate communication of equipment and production activities

Provide leadership to manufacturing and equipment personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance

Sends daily shift reports to other shifts with a breakdown of production and equipment issues

Likely to act as an informal resource for colleagues with less experience

Partners with engineering and production supervisors to develop training for peers and implement improvement projects

Assist equipment operators and provide coaching on how to interact with equipment when required

Expected 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 required

Associate’s degree or higher preferred

2 years of direct pharmaceutical manufacturing experience

2 years of GMP experience

Technical RequirementsProficient in Excel, Word, and other office systems

Ability 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 work

Demonstrates advance understanding of the work tasks assigned

Executes procedures with high quality

Basic understanding of pharmaceutical production operations

Capable of learning unfamiliar principles or techniques with training

Contribute to deviation investigations and corrective / preventative actions

Ability to interpret data, analyze trends, and participate in solutions

Applies 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 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

Leadership Requirements (No Direct Reports)Lead by example according to the Company's values and culture

Develops contacts and builds relationships with peers

Seeks to learn from others

Takes 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.

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.