Lead, Inspection Sun-Fri 11 PM - 7:30 AM
- Bloomington, IN
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Lead, Inspection Sun-Fri 11 PM - 7:30 AMFacility: ManufacturingLocation:Bloomington, IN, USAbout the DepartmentAt 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
- Room Lead
- Has 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 Lead
- Works 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
- 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, 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 Requirements
- 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
- 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