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 Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the facility. The QC team is comprised of the following groups:

 

Microbiology: Microbiology testing such as, microbial enumeration testing and endotoxin testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.

 

Environmental Monitoring: Evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products by performing routine and investigational sampling of the manufacturing environment and associated facilities.

 

Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.

 

Release and In-Process: Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.

 

Method Validation: Analytical testing, data analysis, document writing, and data reporting to support phase appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.

 

Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.

 

Raw Materials: Material inspection, sampling, analytical testing, data analysis, document writing, and data reporting to support the qualification and release of raw materials and components for use in the manufacturing of bulk drug substance and drug product.

 

Other functions: Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly support the entire Quality Control department while performing their specific job functions.

 

 

The Position

This position requires a variety of skills necessary for biotech company operations. The position will leads, as appropriate, multifunction teams to identify root cause(s) and corrective/preventive actions for all deviations. This position will support Quality Control triage and deviation level discussion to ensure it aligns with the company standards. The position will analyze and interpret results in written and oral format. Additionally, this position will support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, and contributions to process improvement initiatives.

 

Essential Functions

Pulls together and leads multifunction teams to troubleshooting, identify root cause(s) and inform Corrective and Preventive Actions measure for all deviations Complete all assigned duties such as training, deviations by the required due date. Required, as appropriate, to identify and seek out other areas where a problem related to an event occurred. Able to work in a multidisciplinary team  to identify and communicate the problem statement effectively to management and/or audit inspectors.. Write clear, concise and accurate investigation reports. Document interviews and analyze the information gathered to identify key findings. Manage multiple investigations and meet deadlines for reporting. Prioritize tasks based on the urgency or complexity of the investigations. Utilize investigation management system (TrackWise), data analysis tools, or other relevant technologies. Assists in authoring technical documents such as SOPs and reports Coordinates with Supervisor to prioritize and schedule activities to meet deadlines Initiates and assists with records in TrackWise Actively participates in team meetings and/or training sessions Other duties as assigned

 

Investigation Team:

Ensure timely completion of investigations through the following activities in Trackwise to include but not limited to: Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance Interview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess the quality impact Conduct investigational meetings with required team members, if applicable Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors Work with cross functional team members to develop appropriate CAPA actions Author/draft investigation reports with minimal guidance Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner Identify and analyze trends arising from individual investigations Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms Present Major or Critical Deviations to the Deviation Review Board (DRB) committee Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPAs Coordinate the review of tr5end CAPAs to the assigned departments and determine their effectiveness

 

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. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

 

Qualifications

Education/Experience: Bachelor’s degree in science field with 5 years of experience, including 2 year GMP experience or regulated industry Master’s degree in science field with 2-4 years of experience, including 2 year GMP experience regulated industry PhD in science field with 0-2 years of experience, including 2 years GMP experience or other regulated industry General laboratory equipment experience, including micropipettes Must be able to read and understand English-written job instructions and safety requirements Preferred: Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines. Intermediate understanding of pharmaceutical laboratory and/or production operations. Prior experience leading deviation investigations using root cause analysis tools. Champion change control and corrective/preventive actions Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions Ability to lead technical calls and discussions regarding investigations, audits or other issues. Strong critical thinking skills-problem solving capabilities. Sense of urgency-looks to drive the investigation to closure and overcome any obstacles. Strong understanding of analytical chemistry and moderately complex lab equipment Familiarity with clean room procedure, aseptic technique, and general lab equipment experience cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge Experience following standard operating procedures (SOP) Technical Requirements: Applies a complete technical understanding and functional knowledge to conduct QC laboratory deviaitons Actively performs investigations and deviations to determine root causes and implement corrective and preventive actions Actively serve as a liaison and technical consultant/advisor to customers and clients, both internally and externally Acts as a technical resource or subject matter expert within own work group/project team, and cross-functionally Act as a mentor to other members of QC Organization Owns Process Improvement Projects Active participant in problem solving and competent at-risk mitigation Behavioral Requirements: Ability to see and hear, read, and write clear English Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing 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 with ability to work effectively under high pressure with multiple deadlines Strong ability to multi-task in a fast pace environment Positive attitude and ability to work with others Ability to process a large volume of work Ability to effectively carry out and implement change Ability to put aside personal opinions and focus on business needs, department needs, or group needs

 

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.