Lead Deviation & CAPA Scientist, GMP Quality

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits

Job summary

Lilly is seeking a qualified professional for Analytical GMP Laboratories (AGL) in Lebanon/Indianapolis to lead deviation investigations and drive CAPA planning. You will author critical reports, collaborate with QA, SMEs, and cross-functional teams, and ensure ALCOA+ data integrity across investigations.

The role emphasizes mentoring, regulatory writing, and risk-based CAPA prioritization within a GMP manufacturing and analytical testing environment.

Qualifications

• BS or MS with GMP manufacturing/QA experience; proven deviation and OOS investigation background.
• Experience authoring protocols, reports, CAPA in regulated environments.
• Strong knowledge of data integrity and regulatory expectations (ALCOA+).

Responsibilities

• Lead deviation and OOS investigations across minor, major, and critical levels.
• Author and review deviation reports, protocols, and CAPA plans with clear rationale.
• Draft CAPA plans and change controls assessing impact on validated processes and systems.
• Troubleshoot and confirmatory testing to distinguish deviations from analytical issues; coordinate with QA and stakeholders.
• Lead governance discussions and may chair deviation review boards.
• Mentor junior investigators on root cause analysis and regulatory writing.

Skills

Root cause analysis

CAPA

Regulatory knowledge

Technical writing

GMP manufacturing

QA collaboration

FDA regulations

TrackWise

Veeva QMS

Problem solving

Leadership

Mentoring

Education

BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or related

MS with 3+ years GMP experience

Tools

TrackWise

Veeva QMS

Laboratory instrumentation

Job description

Lilly is seeking a qualified professional for Analytical GMP Laboratories (AGL) in Lebanon/Indianapolis to lead deviation investigations and drive CAPA planning. You will author critical reports, collaborate with QA, SMEs, and cross-functional teams, and ensure ALCOA+ data integrity across investigations.

The role emphasizes mentoring, regulatory writing, and risk-based CAPA prioritization within a GMP manufacturing and analytical testing environment.