Specialist III, Inspection/Packaging

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.

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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance - effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. 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

Operate manufacturing equipment in order to achieve production goals.

Relationships

Manager. Senior Supervisor, Packaging

Essential Functions

• Process Specialist
• In general, this position provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner
• Provide support for all Client and Regulatory Agency Audits
• Direct client facing interactions including not limited to tours
• Management of process and procedural improvements
• Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP and document revision, review and approval
• Lead and participate in continuous improvement process changes
• Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
• Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
• Proposes improvements to processes and methods
• Direct interaction with Client and Regulatory Auditors
• Lead and guide all tours related to client and regulatory audits
• Acts as a lead, coordinating the work of others
• Works autonomously within established procedures and practices
• Competent at-risk mitigation for function
• Write and revise SOP's, WI's, Batch Records, and Forms
• Support or own work orders, deviations, and audit observations for equipment activities
• Actively participates, suggests solutions to problems, and drives to timelines
• Perform Investigations and Root Cause Analysis in Global Trackwise quality system utilizing technical writing skills
• Ensure documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities
• Create and assist in implementation of Corrective and Preventative Actions (CAPAs)
• Other Tasks as Assigned

Production Analyst

In general, this position's primary duty is to support an assigned production area regarding review of documents, including logs, forms and batch records. This would also include data collection and metric reporting

Has developed expertise in a variety of work processes or activities developed through a combination of job-related training and considerable on-the-job experience

Proficient in Excel/Word/Teams and other data entry software

Leads a team and coordinates work tasks

Monitors team progress

Experienced in resolving corrections and proposes solutions to prevent future corrections

Initiates deviations in Global Trackwise in collaboration with other departments

Performs metrics and data collection in Minitab, Discoverant, JDE, and Sharepoint

Supports manufacturing documentation through real time observations in Sharepoint

Supports MS&T and QA to improve processes

Ability to read, comprehend, and enforce standard operating procedures, work instructions, and master batch records

Operates within clearly defined standard operating procedures and adheres to quality guidelines

Provides guidance on work related tasks in the absence of Value Stream Supervisor

Creates and communicates relevant training materials

Maintains appropriate access, folder permissions, and designations for colleagues as needed

Suggests innovative solutions to routine and complex problems throughout the manufacturing processes and related documentation

Adept at risk mitigation

Works on projects to support the team and business

Responsible for the handling of a company cell phone and being on call if directed

Potential availability outside of normal working hours

Spend time on production floor reviewing documents real time

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 50 pounds. 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 Diploma/GED required with 5+ years' pharmaceutical and/or manufacturing experience required
• Associate degree with 4+ years' pharmaceutical and/or manufacturing experience preferred
• Bachelor's degree in a manufacturing field of study with 3+ year pharmaceutical and/or manufacturing experience preferred
• Audit and inspection experience required
• 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 assignments 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
• Authors and/or approves Standard Operating Procedures (SOPs), Batch Production Records (BPRs) and reports
• 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, especially Hazard Analysis, Fault Tree Analysis, FMEA, etc.

Behavioral Requirements:

Ability to read and write clear English and presenting in an effective manner to the audience

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

Leadership Requirements (No Direct Reports):

Leads by example according to the Company'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 . click apply for full job details