Organization and Position OverviewLilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
As the Foundry is currently in design and construction (startup phase anticipated completion in 2027), the initial position will be fluid and dynamic as we endeavor to support the delivery of the Foundry, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing facility.
Once start up activities are completed, the Quality Assurance Associate, Manufacturing Operations role will perform manufacturing production floor QA support functions which includes day to day Quality oversight of GMP operations, change management and investigation reviews as well as other activities, as assigned.
Responsibilities- 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.
Basic Requirements:- BA/BS degree in Engineering, Science, or other 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.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences: - Effective project and time management skills.
- Demonstrated ability to prioritize and handle multiple concurrent tasks.
- Cognitive abilities, which include problem solving, verbal reasoning, attention detail, critical thinking and analytical competencies.
- Demonstrated strong oral and written communication skills.
- Effective organization/self-management skills
- Demonstrated relevant experience in a cGMP facility.
- Relevant industry experience in high paced working environment.
- Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
- Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
- Ability to identify and prioritize issues and develop & implement solutions.
- High learning agility and ability to deal with ambiguity, uncertainty.
- Demonstrated attention to detail.
Other Information:- Position Location - Initial location: Indianapolis, IN US; Future: Lebanon IN Lilly Medicine Foundry Operations
- Travel Percentage: 5% - 15%
- May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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