Quality Assurance Support Specialist

2 weeks ago

Lebanon, Pennsylvania, United States Lilly Full time

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 therapies, including Gene Therapy. Located in Lebanon, Indiana, this facility will represent Lilly's most advanced manufacturing site, emphasizing the delivery 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 role presents a unique opportunity to contribute to the establishment of a new 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 production. This is an exciting chance to help build a cutting-edge facility and Quality System from the ground up.

The Quality Assurance Operational Support Representative will be tasked with demonstrating leadership, collaboration, and expertise in quality and regulatory standards to provide guidance and influence during the design, verification, and startup phases of the manufacturing areas at Lilly's new Lebanon site. This position is vital for ensuring compliance with Good Manufacturing Practices (GMP) throughout the design, delivery, verification, qualification, and startup processes, ensuring the facility meets regulatory approval. As the project evolves, this role will transition to a site-based process team supporting 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:

  • Expertise in 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, employing Quality by Design (QbD) and Quality Risk Management (QRM) principles.
  • Consult with Network and Global quality teams to ensure a consistent and compliant approach during project execution and startup.
  • Actively engage in necessary design reviews and final design qualification activities.
  • Conduct technical and quality assessments of project documentation 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 reviewing test cases and resolving discrepancies.
  • Collaborate with Site Quality Leadership to develop the vision and strategy for overall site quality operations, focusing on manufacturing areas.
  • Assist in building technical capabilities across a diverse cross-functional team in Quality, including mentoring and training new staff.
  • Promote a strong quality culture by maintaining open communication and encouraging teamwork and employee engagement.
  • Support the definition and 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 as necessary.
  • 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 and Qualification (C&Q) and Verification and Validation oversight, including automation and computer systems validation.

Preferred Qualifications:

  • In-depth knowledge of US, EU, Japan, and other regulations related to pharmaceutical manufacturing.
  • ASQ Certification.
  • Experience in Computer System Quality Assurance.
  • Previous experience with facility or area startup.
  • 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.
  • Knowledge of Manufacturing Execution Systems.
  • Experience with electronic validation software, such as KNEAT.
  • Proven ability to communicate effectively and influence cross-functional teams, with strong oral and written communication skills.
  • Demonstrated problem-solving and decision-making abilities.
  • Technical writing experience.
  • Technical aptitude and 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 activity scope.
  • 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 members and assist in developing talented individuals for future leadership roles. 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 all of our groups.

#WeAreLilly

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