QA Specialist – GMP & API Operations

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 72,000 - 101,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation

Medical/Dental/Vision

Flexible Spending

Life Insurance

Well-being programs

Job summary

Lilly in Indianapolis is seeking a Representative - QA - IAPI (R2-R3) to provide quality support across API operations and ensure GMP compliance. The role involves reviewing GMP docs, deviation/change management, data review, and readiness for inspections; requires a Bachelor's in a scientific field and 2 years' cGMP experience; 24-hour operations support.

Part-time telecommuting may be permitted. Compensation ranges from $71,531 to $101,275 per year with benefits including 401(k), pension, and

Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related field; 2 years with cGMPs and quality systems.
• 2 years' experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs; 1 year of statistics; Deviation and Change Management; Inspection Readiness.
• Must support 24 hour/day operations; Part-time telecommuting may be permitted.

Responsibilities

• Provide quality support to Indianapolis API Operations manufacturing and laboratory areas and ensure robust quality systems and GMP compliance.
• Review and approve key GMP documentation; contribute to deviation investigations and change control proposals; provide quality guidance across functions.
• Maintain quality systems, perform analytical data review, support product and process assessments, and prepare for internal and external regulatory inspections.
• Participate in customer complaint investigations, stability and analytical data review, and disposition of API intermediates and raw materials.
• Contribute to quality system improvement and mentoring of QA Specialists.

Skills

Quality Assurance

GMP Compliance

Statistical Analysis

Deviation Management

Change Management

Inspection Readiness

Manufacturing Experience

Education

Bachelor's degree in Chemical Engineering / Biomedical Engineering / Pharmacology

Job description

Lilly in Indianapolis is seeking a Representative - QA - IAPI (R2-R3) to provide quality support across API operations and ensure GMP compliance. The role involves reviewing GMP docs, deviation/change management, data review, and readiness for inspections; requires a Bachelor's in a scientific field and 2 years' cGMP experience; 24-hour operations support.

Part-time telecommuting may be permitted. Compensation ranges from $71,531 to $101,275 per year with benefits including 401(k), pension, and