Senior Scientist, Qc

5+ years

Not Disclosed

Bloomington

10 April 18, 2025

Job Description

Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Scientist, QC
Location: Bloomington, United States
Job Category: Research

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
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. Join Team Novo Nordisk and help us make what matters.

The Position
This position requires a variety of skills necessary for biotech company operations. The position will perform routine testing of process samples, raw materials, finished products, and stability samples, while adhering to SOPs and working in a cGMP compliant environment. 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.

Relationships

Reports to: Manager, QC

Essential Functions:

Independently executes and properly documents cGMP Quality Control testing
Independently operates basic and moderately complex cGMP Quality Control equipment
Assists in authoring technical documents such as SOPs and reports
Coordinates with Supervisor to prioritize and schedule activities to meet deadlines
Supports continuous process improvement initiatives
Supports training of specific analytical techniques
Performs self-review of analytical data for accuracy and consistency with SOP
Enters data into Laboratory Information Management System (LIMS) or laboratory reports
Performs general lab housekeeping in adherence to 5S standards
Initiates and assists with records in TrackWise
Accurately completes routine and preventive maintenance on basic to moderately complex equipment
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 trend 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 years of experience, including 2 year GMP experience regulated industry
- PhD in science field with 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:
- Strong understanding of analytical chemistry and moderately complex lab equipment
- Experience maintaining and troubleshooting Quality Control 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:

Proficient at all technical requirements of a Scientist AND
Applies a complete technical understanding and functional knowledge to conduct QC laboratory testing as required
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.

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