TZP Frontline QA Representative

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $162,800

Representative – Quality Assurance

Position Title: Representative – Quality Assurance

Position Type: Full Time

Job Level: R1-R4

Location: Lebanon

Job Function: QA

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Quality Assurance representative provides support to Indianapolis 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 record 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 Process & Equipment Support

• Provide direct quality oversight of Indianapolis API production
• Provide quality guidance and recommendations to manufacturing, materials, utilities, and maintenance issues
• Provide technical support to non-routine (e.g., deviation) investigations including root cause analysis, countermeasure development, and implementation of actions
• Identify systemic issues affecting production (deviations, cycle time delays, etc.)
• Participate in the APR process.

Process Optimization & Continuous Improvement

• Review, identify and drive alignment of QA systems across Indianapolis API
• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
• Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.

Adherence to QA/Business Systems

• Provide support to the QA organization for deviation reduction and backlog prevention initiatives
• Participate in and/or lead self inspection activities
• Participate in and/or support regulatory inspections and audits
• Maintain and improve quality systems
• Assist others in the interpretation of regulatory and corporate requirements

Basic Requirements:

• BS in Engineering or science-related field or equivalent experience.  

Additional Preferences:

• Experience in TS/MS, Engineering, QC, QA is preferred
• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Knowledge of protein chemistry & process/cleaning validation.
• Experience leading root cause investigations
• Excellent technical writing skills
• Ability to function in a team environment as a leader and as a member of teams
• Ability to partner/network outside the Indianapolis API site and participate in inspection readiness/continuous improvement initiatives

Additional Information:

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.
• Travel (domestic and international) may be required.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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