What are the responsibilities and job description for the Specialist II, Inspection/Packaging position at Novo Nordisk?
Specialist II, Inspection/Packaging
Facility: Manufacturing
Location:
Bloomington, IN, US
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.
As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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 Drug Product Support department is responsible for supporting the Operations Team in the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. This includes Primary and Secondary Operations. Manufacturing cGMP production support activities include audit preparation, audit performance, documentation and metric tracking, documentation review, deviation identification and authoring, Corrective Actions, Change Management, and process improvements. The department is comprised of three distinct, but integrated, channels. The Manufacturing Auditing team oversees internal and external audits. The Analyst Team reviews batch production records, forms and logs. The third team is Process Specialists and Investigators that investigate and author deviations, implement corrective actions and process improvements.
The Position
Operate manufacturing equipment in order to achieve production goals.
Relationships
Reports to: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.
- Evaluate, identify, and implement improvements needed for processes and procedures
- Provide direct technical support for production processes and implementation of 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
- Direct interaction with Client and Regulatory Auditors
- Lead and guide all tours related to client and regulatory audits
- Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
- Proposes improvements to processes and methods
- 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
- Provide training support for equipment set-up, operation, and changeover
- 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.
- Is multi-skilled or has developed specialized skills through job-related training and considerable on-the-job experience
- Completes work with minimal supervision
- Proficient in Excel/Word/Teams and other data entry software
- Acquires advanced skills to perform routine tasks
- Performs review of master batch records
- 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
- Works on projects to support the team by actively participating and suggesting solutions to problems
- Acts as an informal resource and provides direction to colleagues with less experience
- Adept at risk mitigation
- 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
Education/Experience:
- High School/GED with 3 years’ pharmaceutical and/or manufacturing experience required
- May consider an Associate’s degree (Manufacturing field of study preferred) an accredited university with a minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
- May consider a Bachelors with a minimum of one (1) year of manufacturing experience, preferably in a pharmaceutical manufacturing environment
- Audit and inspection experience preferred
- 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 Catalent'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. 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.
