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Quality Assurance Support Specialist
2 months ago
We are seeking dedicated individuals committed to enhancing the quality of life for people globally.
Company Overview:
Lilly is in the process of developing a state-of-the-art facility dedicated to the production of innovative therapies, including Gene Therapy. Located in Lebanon, Indiana, this facility will represent Lilly's most advanced manufacturing site, focusing on the introduction of groundbreaking products. It will incorporate next-generation manufacturing technologies alongside sophisticated data collection and analysis systems aimed at improving safety, quality, and operational performance. This is a remarkable opportunity to contribute to the establishment of a new manufacturing site, where the successful candidate will play a pivotal role in the design, commissioning, startup, and maintenance of the facility for both clinical and commercial production. This position offers the chance to help create a cutting-edge facility and Quality System from the ground up.
The Quality Assurance Operational Support Representative will exhibit leadership, collaboration, and expertise in quality and regulatory standards to provide guidance and influence in the design, verification, and initiation of manufacturing areas at Lilly's new Lebanon site. This role is crucial for ensuring compliance with Good Manufacturing Practices (GMP) throughout the design, delivery, verification, qualification, and startup phases, ensuring the facility meets regulatory standards. As the project advances, this position will transition to support site-based process teams in various manufacturing areas, including:
- ATMP Gene Therapy Drug Substance Manufacturing
- ATMP Gene Therapy Parenteral Manufacturing
- Quality Control Laboratory
- Packaging Operations
- Warehouse Logistics
- Facility, Utility, and Maintenance Management
Key Responsibilities:
- 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, applying Quality by Design (QbD) and Quality Risk Management (QRM) principles while ensuring the integration of Global Quality System requirements.
- Consult with Network and Global quality teams as necessary to ensure a consistent and compliant approach during the project and startup phases.
- Actively engage 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.
- Oversee the verification and qualification of manufacturing equipment and facilities, including the review of test cases, execution of tests, and resolution of discrepancies.
- Collaborate with Site Quality Leadership to shape the vision and strategy for overall site quality operations, with a focus on manufacturing areas.
- Assist in developing technical capabilities within a diverse cross-functional team in Quality, mentoring and training new staff.
- Promote a strong quality culture by maintaining open communication and encouraging teamwork and employee engagement.
- Support the planning and execution of inspection readiness activities, including site self-inspections.
- Lead project initiatives that support both the project and Quality functions.
- Address or escalate compliance issues to project, site, and Quality Management as necessary.
- Provide guidance on deviations, observation management, 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, specifically in Quality Assurance roles.
- Prior experience with Commissioning and Qualification (C&Q) and Verification and Validation oversight, including automation and computer systems validation.
Preferred Qualifications:
- Proven knowledge of US, EU, Japan, and other regulations related to pharmaceutical manufacturing.
- ASQ Certification.
- Experience in Computer System Quality Assurance.
- Previous experience in facility or area startup projects.
- Familiarity with gene therapy drug substance processes, including equipment preparation, virus preparation/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.
- Proficiency in using KNEAT or other electronic validation software.
- Strong communication skills, with the ability to influence cross-functional teams effectively.
- Demonstrated problem-solving and decision-making abilities.
- Experience in technical writing.
- Technical aptitude with the capability to train and mentor others.
Additional Information:
- Willingness to work 8-12 hour shifts onsite.
- Flexibility to work remotely during the project phase based on the nature of activities.
- Potential travel (10-25%) or short-term assignments at other Lilly sites may be required to establish specific computer system 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 strong support networks for their members and help our company cultivate talented individuals for future leadership roles.
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