QA REPRESENTATIVE City

BioSpace
US - Indiana - Columbia City
November 1, 2024
IT

Job Details

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.

Organization Overview:

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. 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 leadership 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.

The Quality Assurance representative provides support to 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 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 manufacturing site
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:

Bachelor's degree and 1+ year of relevant pharmaceutical experience OR
5+ years of directly applicable pharmaceutical QA experience

Additional Preferences:

Experience in TS/MS, Engineering, QC, QA is preferred
Good knowledge of cGMP and external Regulations
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 site and participate in inspection readiness/continuous improvement initiatives

Additional Info:

Potential for short-term assignments and travel OUS during the start-up period.

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 ( ) 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.
• WeAreLilly

Read the full job description and apply online on the recuiter's web-site

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