Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.
Job Position Overview:The Quality Assurance representative provides support to LP1 API Operations manufacturing and ensures quality systems and GMP compliance. The QA representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production recipe revisions, validations and batch dispositions. The QA representative's position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.
Responsibilities:- Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements.
- Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives.
- Work with cross functional teams to implement QA objectives.
- Prepare for and participate in internal and external regulatory inspections.
Basic Requirements:- BS in Engineering or science related field.
- 2+ year of cGMP manufacturing experience.
- 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 Skills/Preferences:- Previous experience in pharmaceutical industry.
- Previous experience in QA, TS/MS QC or Engineering.
- Prior work with external regulations.
- Demonstrated strong oral and written communication and interpersonal skills.
- Demonstrated decision making and problem-solving skills.
Additional Information:- The normal schedule for this position is Monday-Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule.
- Travel Percentage (%): N/A
- This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
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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