Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQC Indianapolis QA Systems
Recruiter: Katherine Hall

This information is for internals only. Please do not share outside of the organization.

Your Role:

The Lead Investigator will oversee and conduct investigations in accordance with company policies, applicable cGMP FDA, EMA, and other global pharmaceutical regulations. Responsibilities include investigating deviations, leading root cause analysis, writing reports, and establishing CAPAs using SMART methodology.

Responsibilities include but are not limited to:

• Maintain oversight of the QA program from a QMS perspective, ensuring compliance and on-time closures.
• Collaborate with cross-functional teams, facilitate problem-solving, and drive continuous improvement efforts.
• Write, review, and approve Deviations, CAPAs, Complaints, as required.
• Lead and inspire cross-functional teams, fostering a culture of compliance and continuous improvement.
• Other responsibilities and projects, as assigned.
• Client facing meetings to drive timely closure of investigations.
• Investigate deviations/non-conformances of all levels: MINOR, MAJOR, and CRITICAL.
• Create SMART CAPAs and Effectiveness Checks as necessary.
• Track and trend data.

Who You Are:

Minimum Qualifications:

• High School Diploma or GED.
• 5 years of experience in Quality Assurance or compliance within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing environments.

Preferred Qualifications:

• Experience with cGMP, Data Integrity, and Quality Systems.
• Experience successfully leading and managing investigations and CAPAs.
• Experience collaborating with regulatory agencies and conducting audits or inspections.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.