Senior cGMP Investigator

Initial Therapeutics, Inc.; Bloomington (IN); On-site; USD 65,000 - 100,000; Full time

Job summary

An established industry player seeks a Quality Assurance professional to lead investigations and ensure compliance with regulatory standards. This role involves collaborating with multi-functional teams to troubleshoot issues, develop corrective actions, and maintain high-quality standards. You'll have the opportunity to mentor others and drive improvements in a dynamic environment focused on patient care. If you're passionate about quality and eager to make a significant impact in the pharmaceutical industry, this position offers a fulfilling career path with ample growth opportunities.

Benefits

Generous paid time off

Health Insurance

Dental Insurance

Vision Insurance

401K contribution

Paid parental leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Access to pharmaceutical products

Qualifications

• 5-8 years of experience in a regulated industry with 2 years of GMP experience.
• Bachelor's degree in a STEM discipline; Master's preferred.

Responsibilities

• Lead multi-function teams to troubleshoot and identify root causes of deviations.
• Complete comprehensive deviation reports and present findings.

Skills

Root Cause Analysis

GMP Compliance

Critical Thinking

Effective Communication

Problem Solving

Education

Bachelor's degree in STEM discipline

Master's degree or higher

Tools

Excel

Word

Quality Management Software

Job description

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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. 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 Assurance department is responsible for all aspects of the quality assurance functions, ensuring compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition.

The Position

Relationships

Reports to: Caleb Buuck

Essential Functions

• Pulls together and leads, as appropriate, multi-function teams to troubleshoot, identify root cause(s), and inform on the Corrective and Preventative measures for all deviations.
• Reviews the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company standard and is appropriately classified.
• Works with the Quality unit to address any discrepancies or concerns with the classification.
• Completes all assigned tasks including training by the required due date.
• Seeks out and identifies, on location, the processes, equipment, and any other areas where a problem related event occurred to view and understand first-hand what happened or could happen.
• Works with the team to clearly identify and communicate the problem statement that can focus the investigation.
• Effectively works with a team of SME’s to quickly identify the potential scope of an issue and escalates to Leadership to ensure proper actions with customers and regulatory agencies are managed.
• Conducts interviews logically to uncover issues and understand the ability to identify required information and/or data to aid in the investigation.
• Develops the framework for the investigation hypothesis to allow the SME’s and teams to assess, challenge, and provide necessary expertise.
• Identifies all possible corrective and preventative measures through the use of engineering solutions.
• Completes all investigation information into a comprehensive deviation report that clearly defines the problem, the facts, and evidence that drives a strong root cause conclusion.
• Provides a summary presentation of the draft investigation to the deviation review-board with the facts and CAPA(s) to obtain Final Quality unit approval.
• Defines and works with the SME’s to develop a CAPA effectiveness plan as required.
• Follows up post-investigation or in the event of repeat deviations to understand the reason and assess prior analysis and actions.
• Acts as a mentor to investigators and provides assistance including expertise when needed.
• Leads and presents at Team Meetings and Huddles.
• Completes and closes a minimum of 10 Major Deviations per month.

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. 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:
• Bachelor’s degree in STEM discipline.
• Master’s degree or higher preferred.
• 5-8 years of experience.
• 2 years of GMP experience required or regulated industry.

• Technical Requirements:
• Proficient in Excel, Word, and other office systems.
• Prior work experience with quality, operations and/or scientific management software.
• Ability to understand and independently apply CGMPs as it relates to clinical and commercial operations.
• Demonstrates understanding of the work tasks assigned.
• 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.
• Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions.

• Behavioral Requirements:
• Ability to communicate effectively and follow/retain detailed written and verbal instructions.
• Detail-oriented and well organized with the ability to work effectively under high pressure with multiple deadlines.
• Strong critical thinking skills – proven problem-solving capabilities.
• Clear communicator - drives actions and sets expectations.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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.