Principal Representative, Quality Assurance

Job Details

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:

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.

About The Position

Relationships

Reports to Manager or Director

Essential Functions

Collaborates with Quality Control, Materials Management, Supply Chain and Manufacturing to ensure that materials are available for use

Provides support for the introduction of new material and service suppliers

Assists in the customer and supplier auditing process providing administrative support including information gathering and organization

Provide quality support to Quality Control, Materials Management Center, and Supply Chain

Review / Approve all incoming Material Specification Sheets

Review / Release all inspected incoming materials

Act as subject matter expert to internal and external customers regarding supplier qualification, material receipt / inspection / release and storage requirements

Review and approve supply quality related records (e.g. deviations change controls, etc.) to ensure compliance to regulatory and procedural requirements is maintained

Process supplier complaint investigation records and drive CAPA and disposition decisions

Gather and report area metrics

Perform supplier risk assessments

Support maintenance of the approved supplier list

Compile supplier pre audit data packages

Support supplier performance monitoring program

Assess damaged materials / product within warehouse spaces

Perform routine Gemba walks of warehouse spaces

Perform system, cold storage equipment, and material holds as appropriate

Follow all safety and environmental requirements in the performance of duties

Other duties as assigned

Product Quality

Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports

Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations

Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships

Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements

Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems

Supports execution of QA on the Floor program

Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms

Reviews executed batch records

Ensures all in-process specifications are met

Ensures all corrections found are made to batch records

Interacts with clients in a professional manner to ensure timely resolution of post-disposition corrections

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. Walking and/or standing for up to 8 to 12 hours depending on assigned area. Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

Qualifications

STEM Bachelor's degree, highly preferred

8 + years of relevant experience with Bachelor's degree, required

8 years of experience or demonstrated excellence in role with justification, required

8 year GxP experience or other regulated industry, required

Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies

Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures

Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects

Must be able to read and understand English-written job instructions and safety requirements

Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred

A strong working knowledge of quality systems and processes, preferred

Technical Requirements

Ability to use Excel, Word, and other office systems

Ability to learn and use quality management software such as TrackWise® or ComplianceWire®

Ability to understand and independently apply CGMPs to everyday work

Demonstrates understanding of the work tasks assigned

Executes procedures of moderate complexity with high quality

Intermediate understanding of pharmaceutical laboratory and/or production operations

Capable of learning unfamiliar principles or techniques with training

Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor

Ability to problem solve and execute and monitor corrective actions

Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions

Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor

Seeks best practices for daily work activities

Behavioral Requirements

Ability to see and hear and read and write clear English

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, in a professional and accurate manner

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

Lead by example according to the Company's values and culture

Builds on contacts and relationships with peers

Take 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 . This contact is for accommodation requests only and cannot be used to inquire about the status of applications.