Quality Assurance Operational Support

Lilly • Lebanon, IN

1d • $66,000 - $171,600 • Onsite

About The Position

Lilly is constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply. This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide oversight for the delivery and daily operation of the Lilly Advanced Therapies (LP2) site. The QA Operational Support Representative provides guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Operational Support Representative is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Requirements

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Demonstrated ability to communicate with and influence cross-functional teams including good 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
• ASQ Certified
• Experience with equipment verification and validation oversight including automation and computer systems validation.
• Previous facility or area start up experience.
• Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging.
• Proficiency with computer systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office products.

Responsibilities

• Adhere to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals
• Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures
• Oversee verification of manufacturing equipment/facilities from definition of requirements thru design and testing
• Lead, mentor, and coach operations and support personnel on quality matters, e.g. good documentation practices, data integrity and regulatory compliance.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the definition and execution of inspection readiness activities and provide support for internal / external regulatory inspections
• Lead/support Process Team initiatives needed in support of the Site and Quality function
• Ensure regular presence in operational areas to monitor GMP programs and quality systems
• Provide guidance and triage for deviations and change controls
• Support and/or execute review of batch records and release of drug substance, drug product, and finished product batches for Clinical Trial and commercial use
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach to facility delivery and operation

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level