BioSpace
Quality Assurance - Operational Support
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 work worldwide 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 a cutting‑edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focusing on the delivery of the next wave of innovative products. The site will incorporate next‑generation manufacturing technologies and advanced data collection and analysis platforms that will improve safety, quality, and process performance. This is a unique opportunity to be part of the team building a greenfield manufacturing site. You will help design, commission, start up, and maintain the facility for both clinical and commercial supply, and build a state‑of‑the‑art facility and Quality System from the ground up.
The Quality Assurance Operational Support Representative demonstrates leadership, teamwork, and quality and regulatory knowledge. The role provides guidance, consultation, and influence in the design, verification, and startup of the manufacturing areas at Lilly’s new Lebanon, Indiana (LP2) site. The QA Operational Support position ensures GMP compliance in the design, delivery, verification, qualification, and start‑up processes. As the project progresses, the role will transition to a site‑based process team supporting one of the following manufacturing areas: ATMP Gene Therapy Drug Substance Manufacturing, ATMP Gene Therapy Parenteral Manufacturing, QC Laboratory, Packaging, Warehouse Logistics, Facility, Utility, and Maintenance.
Responsibilities
Knowledge of cGMP practices including good documentation practices, data integrity, and regulatory compliance.
Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas using QbD and QRM principles and ensuring integration of Global Quality System requirements into the design.
Consult with Network and Global quality groups to ensure a consistent and compliant approach is executed during the project and startup phases.
Participate in required design reviews and final design qualification activities.
Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards and local quality procedures.
Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
Work with Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross‑functional support focused on the manufacturing areas.
Support the site organization in building technical capability for a diverse cross‑functional staff in Quality, the project team, and area process teams, including mentoring and training of new quality and other project staff.
Foster a strong quality culture, maintain open communications, and promote teamwork and employee participation.
Support the definition and execution of inspection readiness activities, including support of site self‑inspections in GQA.
Lead project initiatives needed in support of the project and quality function.
Resolve or escalate any compliance issues to the project, site, and Quality Management.
Provide guidance for deviations, observation handling, change control proposals, document creation, and revisions.
Basic Requirements
Bachelor’s degree in a relevant field (preference for scientific or engineering).
3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
Additional Preferences
Demonstrated knowledge and use of US, EU, Japan, and other regulations in pharmaceutical manufacturing.
ASQ Certified.
Computer System Quality Assurance experience.
Previous facility or area startup experience.
Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, or drug product manufacturing processes like formulation, filling/visual inspection, and packaging.
Previous experience with lab equipment delivery and qualification.
Previous experience managing utilities, facilities, maintenance, and warehouse logistics.
Previous experience with Manufacturing Execution Systems.
Previous use of KNEAT or other electronic validation software.
Demonstrated ability to communicate with and influence cross‑functional teams, including oral and written communication skills.
Demonstrated strong problem‑solving and decision‑making skills.
Previous technical writing experience.
Technical aptitude and ability to train and mentor others.
Additional Information
Ability to work 8‑12 hour shifts on Monday‑Friday in the Lebanon, IN office.
Position may require travel (10–25%) or potentially a short‑duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge.
Equal Employment Opportunity Lilly is proud to be an EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at the link provided.
Compensation & Benefits 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 employees will also be eligible for company bonus incentives, 401(k) participation, pension, vacation benefits, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, and well‑being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs.
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Lilly is currently constructing a cutting‑edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focusing on the delivery of the next wave of innovative products. The site will incorporate next‑generation manufacturing technologies and advanced data collection and analysis platforms that will improve safety, quality, and process performance. This is a unique opportunity to be part of the team building a greenfield manufacturing site. You will help design, commission, start up, and maintain the facility for both clinical and commercial supply, and build a state‑of‑the‑art facility and Quality System from the ground up.
The Quality Assurance Operational Support Representative demonstrates leadership, teamwork, and quality and regulatory knowledge. The role provides guidance, consultation, and influence in the design, verification, and startup of the manufacturing areas at Lilly’s new Lebanon, Indiana (LP2) site. The QA Operational Support position ensures GMP compliance in the design, delivery, verification, qualification, and start‑up processes. As the project progresses, the role will transition to a site‑based process team supporting one of the following manufacturing areas: ATMP Gene Therapy Drug Substance Manufacturing, ATMP Gene Therapy Parenteral Manufacturing, QC Laboratory, Packaging, Warehouse Logistics, Facility, Utility, and Maintenance.
Responsibilities
Knowledge of cGMP practices including good documentation practices, data integrity, and regulatory compliance.
Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas using QbD and QRM principles and ensuring integration of Global Quality System requirements into the design.
Consult with Network and Global quality groups to ensure a consistent and compliant approach is executed during the project and startup phases.
Participate in required design reviews and final design qualification activities.
Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards and local quality procedures.
Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
Work with Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross‑functional support focused on the manufacturing areas.
Support the site organization in building technical capability for a diverse cross‑functional staff in Quality, the project team, and area process teams, including mentoring and training of new quality and other project staff.
Foster a strong quality culture, maintain open communications, and promote teamwork and employee participation.
Support the definition and execution of inspection readiness activities, including support of site self‑inspections in GQA.
Lead project initiatives needed in support of the project and quality function.
Resolve or escalate any compliance issues to the project, site, and Quality Management.
Provide guidance for deviations, observation handling, change control proposals, document creation, and revisions.
Basic Requirements
Bachelor’s degree in a relevant field (preference for scientific or engineering).
3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
Additional Preferences
Demonstrated knowledge and use of US, EU, Japan, and other regulations in pharmaceutical manufacturing.
ASQ Certified.
Computer System Quality Assurance experience.
Previous facility or area startup experience.
Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, or drug product manufacturing processes like formulation, filling/visual inspection, and packaging.
Previous experience with lab equipment delivery and qualification.
Previous experience managing utilities, facilities, maintenance, and warehouse logistics.
Previous experience with Manufacturing Execution Systems.
Previous use of KNEAT or other electronic validation software.
Demonstrated ability to communicate with and influence cross‑functional teams, including oral and written communication skills.
Demonstrated strong problem‑solving and decision‑making skills.
Previous technical writing experience.
Technical aptitude and ability to train and mentor others.
Additional Information
Ability to work 8‑12 hour shifts on Monday‑Friday in the Lebanon, IN office.
Position may require travel (10–25%) or potentially a short‑duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge.
Equal Employment Opportunity Lilly is proud to be an EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at the link provided.
Compensation & Benefits 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 employees will also be eligible for company bonus incentives, 401(k) participation, pension, vacation benefits, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, and well‑being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs.
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