QA Associate, GMP Manufacturing Operations

BioSpace; Lebanon (IN); Sur place; USD 65 000 - 169 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Pension

Vacation benefits

Health benefits

Résumé du poste

Lilly is seeking a Quality Assurance Associate, Manufacturing Operations for the Lilly Medicine Foundry. The role focuses on day‑to‑day QA support of GMP operations, change management, and investigation reviews as the foundry scales from startup to full GMP manufacturing.

Initial location is Indianapolis, IN with future site in Lebanon, IN. You will partner with plant teams and cross‑functional groups to ensure compliance and operational excellence in a high‑paced biotech/pharma environment.

Qualifications

• BA/BS degree in Engineering, Science, or other related field; minimum 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Understand GMP requirements for early phase development and manufacturing in quality management systems.
• Authorized to work in the United States on a full‑time basis; Lilly will not sponsor visas.

Responsabilités

• Participate in creating and maintaining a safe work environment.
• Foster a strong collaborative quality culture including open communication and teamwork with cross‑functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
• Review GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross‑functionally with plant teams to provide operational support and issue management.
• Assist with inspection readiness activities.
• Effectively communicate with internal and external stakeholders.

Connaissances

Project management

Time management

Prioritization

Communication skills

Organization

cGMP experience

Problem solving

Root cause analysis

Adaptability

Attention to detail

Formation

BA/BS in Engineering or Science

Description du poste

Lilly is seeking a Quality Assurance Associate, Manufacturing Operations for the Lilly Medicine Foundry. The role focuses on day‑to‑day QA support of GMP operations, change management, and investigation reviews as the foundry scales from startup to full GMP manufacturing.

Initial location is Indianapolis, IN with future site in Lebanon, IN. You will partner with plant teams and cross‑functional groups to ensure compliance and operational excellence in a high‑paced biotech/pharma environment.