Quality Assurance Associate, GMP Manufacturing Ops

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 65 000 - 169 000; Plein temps

Résumé du poste

Lilly, headquartered in Indianapolis, Indiana, is seeking a Quality Assurance Associate for Manufacturing Operations to support GMP activities, review documentation, and collaborate with cross-functional teams to maintain product quality and regulatory compliance. This startup-era role requires problem-solving and strong communication as the site scales toward full GMP operations. It may involve travel and on-call duties.

Qualifications

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

Responsabilités

• Participate in creating and maintaining a safe work environment.
• Foster a strong collaborative quality culture including maintaining open communication and promoting teamwork and employee participation in the work group and 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 the plant teams to provide operational support, and issue management.
• Assist with inspection readiness activities.
• Effectively communicate with internal and external stakeholders.

Connaissances

Attention to detail

Problem solving

Communication skills

Time management

Flexibility

Cross-functional teamwork

Formation

BA/BS degree in Engineering, Science, or related field

Description du poste

Lilly, headquartered in Indianapolis, Indiana, is seeking a Quality Assurance Associate for Manufacturing Operations to support GMP activities, review documentation, and collaborate with cross-functional teams to maintain product quality and regulatory compliance. This startup-era role requires problem-solving and strong communication as the site scales toward full GMP operations. It may involve travel and on-call duties.