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Senior Scientist, Qc

2-6 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Scientist – Quality Control
Location: Bloomington, United States
Job Category: Research


About the Department

At Novo Nordisk, we strive to make a difference. For over 100 years, we have led the way in diabetes care, and our employees have the opportunity to embark on life-changing careers. By joining Novo Nordisk, you will help improve the quality of life for millions of people worldwide.

As part of Novo Nordisk, Catalent, Indiana LLC, located in Bloomington, Indiana, is a state-of-the-art facility offering integrated services from process and formulation to clinical and commercial biomanufacturing, drug product fill/finish, and packaging. The Bloomington campus is recognized for its talented teams who collaborate with innovators to develop, manufacture, and supply products to patients globally.


What We Offer You:

  • Competitive Compensation: Leading pay and annual performance bonus for all positions.

  • Generous Paid Time Off: 14 paid holidays.

  • Comprehensive Benefits (Effective Day One):

    • Health Insurance

    • Dental Insurance

    • Vision Insurance

  • Retirement Plans: Guaranteed 8% 401K contribution plus company match option.

  • Family-Focused Benefits:

    • 14 weeks of paid parental leave.

    • 6 weeks of paid family medical leave.

  • Additional Perks:

    • 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 support your career growth. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.


About the Quality Control (QC) Team

The Quality Control team ensures the safety, quality, identity, purity, and potency of products through testing of raw materials, manufacturing environments, and final products. The QC team includes:

1. Microbiology:

  • Conducts microbial enumeration testing and endotoxin testing.

  • Analyzes data and generates reports for bulk drug substances and drug products.

2. Environmental Monitoring:

  • Evaluates microbial controls to prevent contamination.

  • Conducts routine and investigational sampling of manufacturing environments.

3. Stability:

  • Performs analytical testing for ICH stability studies.

  • Determines stability of bulk drug substances and drug products.

4. Release & In-Process Testing:

  • Conducts analytical testing to support bulk drug substances and drug product releases.

5. Method Validation:

  • Supports phase-appropriate method validation for analytical methods.

  • Ensures accurate analytical results for Stability and Release & In-Process teams.

6. Sample Management:

  • Manages and oversees samples for manufacturing, stability, and method validation.

  • Maintains stability chambers and laboratory critical reagents.

7. Raw Materials:

  • Conducts material inspection, sampling, and testing for raw materials and components.

  • Ensures compliance for manufacturing of bulk drug substances and drug products.

8. Other Functions:

  • Technical data review, training, instrument maintenance, lead investigator roles, and LIMS administration.


The Position

This role involves performing routine testing of process samples, raw materials, finished products, and stability samples within a cGMP-compliant environment. Responsibilities include analyzing and interpreting results, supporting preventative maintenance, maintaining GMP quality systems, and contributing to process improvements.

Essential Functions:

  • Execute and document cGMP Quality Control testing independently.

  • Operate basic and moderately complex cGMP Quality Control equipment.

  • Assist in authoring technical documents such as SOPs and reports.

  • Prioritize and schedule activities to meet deadlines.

  • Support continuous process improvement initiatives.

  • Train personnel on analytical techniques.

  • Review analytical data for accuracy and consistency.

  • Enter data into LIMS or laboratory reports.

  • Maintain general lab housekeeping per 5S standards.

  • Initiate and assist with records in TrackWise.

  • Complete routine and preventive maintenance on equipment.

  • Participate actively in team meetings and training sessions.

  • Perform other duties as assigned.

Investigation Team Responsibilities:

  • Complete investigations in TrackWise, including:

    • Coordinating immediate actions with QA and management.

    • Interviewing Subject Matter Experts (SMEs) and employees.

    • Conducting investigational meetings.

    • Utilizing problem-solving techniques for root cause determination.

    • Developing corrective and preventive actions (CAPAs).

    • Authoring investigation reports.

    • Identifying and analyzing investigation trends.

    • Supporting data collection for management reviews and KPI reports.

    • Presenting major deviations to the Deviation Review Board (DRB).

    • Managing CAPA activities and determining their effectiveness.


Physical Requirements:

  • Frequent sitting, standing, walking, reading, and computer use.

  • Occasional bending, kneeling, and carrying.

  • Frequent lifting up to 10 lbs.; occasional lifting up to 50 lbs.

  • Exposure to irritants, electrical equipment, sharp instruments, and hazardous materials (safety protocols must be followed).


Qualifications

Education & Experience:

  • Bachelor’s Degree in a Science Field: 6 years of experience (2 years in GMP or regulated industry).

  • Master’s Degree in a Science Field: 2-4 years of experience (2 years in GMP or regulated industry).

  • PhD in a Science Field: Minimum 2 years in GMP or regulated industry.

  • General laboratory equipment experience, including micropipettes.

  • Ability to read and understand English job instructions and safety requirements.

Preferred Qualifications:

  • Strong understanding of analytical chemistry and lab equipment.

  • Experience in Quality Control equipment maintenance and troubleshooting.

  • Familiarity with clean room procedures and aseptic techniques.

  • Knowledge of cGMP, Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).

  • Experience following SOPs.

Technical & Behavioral Requirements:

  • Proficiency in QC laboratory testing and investigations.

  • Ability to serve as a technical resource or SME.

  • Strong problem-solving skills and risk mitigation ability.

  • Effective communication and adaptability.

  • Detail-oriented with the ability to work under pressure and meet deadlines.

  • Positive attitude and strong teamwork skills.

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