Associate, Quality Assurance, Process Manufacturing-Lilly Medicine Foundry
Eli Lilly and Company
9 hours ago
On-site
Lebanon, IN
$65,250 - $169,400 USD yearly
Operations
Organization And Position Overview:
- Supports quality functions associated with Lilly Technical Center in Indianapolis initially; then transfers to startup activities at the Lilly Medicine Foundry and on-site quality support of cGMP operations. Position will involve implementing systems/business processes for GMP operations and building site culture.
Responsibilities:
- Participate in creating and maintaining a safe work environment, including leading/enabling safety efforts for the Quality team.
- Support cross-functional teams, facilitate decision making, and drive progress.
- Foster a collaborative quality culture (open communications, teamwork, and employee participation).
- Ensure compliance with applicable laws, regulations, and guidelines for early phase GMP activities.
- Review and approve GMP documentation (procedures, deviations, technical reports, change controls, etc.).
- Influence and oversee Facility, Utility, Maintenance and Equipment (FUME) Qualification/Maintenance/Calibration programs.
- Facilitate decision making within the team under tight deadlines.
- Communicate effectively with internal and external stakeholders.
Basic Requirements:
- BA/BS in Engineering, Science, or related field; minimum 3 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
- Understand GMP requirements for early phase development and manufacturing; application of quality management systems.
- Prior experience in equipment/utilities qualification, calibration, and maintenance.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences:
- Relevant experience in a cGMP facility.
- Experience in a high-paced environment.
- Strong oral and written communication.
- Critical thinking/technical problem-solving, including root cause analysis/troubleshooting.
- Flexibility to adapt to frequent changes and priorities.
- Ability to establish relationships and influence peers/business partners.
- Ability to identify/prioritize issues and develop/implement solutions.
- High learning agility; can work with ambiguity/uncertainty.
- Attention to detail.
Other Information:
- Location: Initial Indianapolis, IN; Future: Lebanon IN Lilly Medicine Foundry Operations.
- Travel: 5%–15%.
- On-call support may be required outside normal hours (nights, weekends, holidays).
- Supports quality functions associated with Lilly Technical Center in Indianapolis initially; then transfers to startup activities at the Lilly Medicine Foundry and on-site quality support of cGMP operations. Position will involve implementing systems/business processes for GMP operations and building site culture.
Responsibilities:
- Participate in creating and maintaining a safe work environment, including leading/enabling safety efforts for the Quality team.
- Support cross-functional teams, facilitate decision making, and drive progress.
- Foster a collaborative quality culture (open communications, teamwork, and employee participation).
- Ensure compliance with applicable laws, regulations, and guidelines for early phase GMP activities.
- Review and approve GMP documentation (procedures, deviations, technical reports, change controls, etc.).
- Influence and oversee Facility, Utility, Maintenance and Equipment (FUME) Qualification/Maintenance/Calibration programs.
- Facilitate decision making within the team under tight deadlines.
- Communicate effectively with internal and external stakeholders.
Basic Requirements:
- BA/BS in Engineering, Science, or related field; minimum 3 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
- Understand GMP requirements for early phase development and manufacturing; application of quality management systems.
- Prior experience in equipment/utilities qualification, calibration, and maintenance.
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas/work authorization.
Additional Preferences:
- Relevant experience in a cGMP facility.
- Experience in a high-paced environment.
- Strong oral and written communication.
- Critical thinking/technical problem-solving, including root cause analysis/troubleshooting.
- Flexibility to adapt to frequent changes and priorities.
- Ability to establish relationships and influence peers/business partners.
- Ability to identify/prioritize issues and develop/implement solutions.
- High learning agility; can work with ambiguity/uncertainty.
- Attention to detail.
Other Information:
- Location: Initial Indianapolis, IN; Future: Lebanon IN Lilly Medicine Foundry Operations.
- Travel: 5%–15%.
- On-call support may be required outside normal hours (nights, weekends, holidays).