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Quality Assurance Support Specialist
2 months ago
We're seeking individuals who are committed to enhancing the quality of life for people globally.
Organization Overview:
Lilly is in the process of developing a state-of-the-art facility dedicated to the production of innovative modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will represent Lilly's most advanced manufacturing site, concentrating on the introduction of groundbreaking products. It will incorporate next-generation manufacturing technologies alongside sophisticated data collection and analysis systems aimed at enhancing safety, quality, and operational performance. This presents a unique opportunity to contribute to the establishment of a greenfield manufacturing site, where the successful candidate will play a crucial role in the design, commissioning, startup, and maintenance of the facility for both clinical and commercial supply.
The Quality Assurance Operational Support Representative will be pivotal in showcasing leadership, collaboration, and expertise in quality and regulatory standards to provide guidance, consultation, and influence throughout the design, verification, and startup phases of the manufacturing areas at Lilly's new Lebanon site. This role is essential for ensuring compliance with Good Manufacturing Practices (GMP) during the design, delivery, verification, qualification, and startup processes to secure regulatory approval for the facility. As the project evolves, this position will transition to a site-based process team supporting various manufacturing areas, including:
- ATMP Gene Therapy Drug Substance Manufacturing
- ATMP Gene Therapy Parenteral Manufacturing
- QC Laboratory
- Packaging
- Warehouse Logistics
- Facility, Utility, and Maintenance
Key Responsibilities:
- Comprehensive understanding of cGMP practices, including documentation standards, data integrity, and regulatory compliance.
- Serve as a cGMP liaison, collaborating with Global Facility Delivery and Lilly project teams to finalize the detailed design of assigned areas while integrating Global Quality System requirements.
- Engage with Network and Global quality groups to ensure a consistent and compliant approach during project execution and startup phases.
- Actively participate in design reviews and final design qualification activities.
- Conduct technical and quality assessments of project documents to ensure adherence to Lilly Global Quality Standards and local quality procedures.
- Provide quality oversight for the verification and qualification of manufacturing equipment and facilities, including the review of test cases and resolution of discrepancies.
- Collaborate with Site Quality Leadership to shape the vision and strategy for overall site quality operations, focusing on manufacturing areas.
- Assist in developing technical capabilities within a diverse cross-functional team, including mentoring and training new quality and project staff.
- Promote a strong quality culture by fostering open communication and teamwork.
- Support the execution of inspection readiness activities, including site self-inspections.
- Lead project initiatives that support the quality function.
- Address or escalate compliance issues to project, site, and Quality Management.
- Provide guidance on deviations, observation handling, change control proposals, and document revisions.
Basic Qualifications:
- Bachelor's degree in a relevant field, preferably in a scientific or engineering discipline.
- Minimum of 3 years of experience in the pharmaceutical manufacturing industry in Quality Assurance roles.
- Prior experience with Commissioning & Qualification (C&Q) and Verification and Validation oversight, including automation and computer systems validation.
Preferred Qualifications:
- Demonstrated knowledge of US, EU, Japan, and other regulations pertaining to pharmaceutical manufacturing.
- ASQ Certification.
- Experience in Computer System Quality Assurance.
- Previous involvement in facility or area startup projects.
- Familiarity with gene therapy drug substance processes, including equipment preparation, virus banking, inoculation, purification, and drug product manufacturing processes.
- Experience with laboratory equipment delivery and qualification.
- Background in managing utilities, facilities, maintenance, and warehouse logistics.
- Experience with Manufacturing Execution Systems.
- Familiarity with KNEAT or other electronic validation software.
- Proven ability to communicate effectively and influence cross-functional teams.
- Strong problem-solving and decision-making skills.
- Experience in technical writing.
- Technical aptitude and capability to train and mentor others.
Additional Information:
- Willingness to work 8-12 hour shifts onsite.
- This position may offer a flexible working environment during the project phase, allowing for periodic remote work based on activity scope.
- Some travel (10-25%) may be required, including potential short-term assignments at other Lilly sites for specific validation and data integrity knowledge.
Lilly is an EEO/Affirmative Action Employer and does not discriminate based on 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) provide robust support networks for members and assist in developing future leaders. 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, and Working and Living with Disabilities. Learn more about our groups.
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