Lilly

Healthcare

SeniorAssociate-ExternalManufacturingQA

$65–169k Lebanon, Indiana, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior Associate - External Manufacturing QA at Lilly. Skills: External Manufacturing QA, Contract Manufacturers, Quality Assurance. Provide quality oversight of contract manufacturers. Manage daily contract manufacturing activities”

What You'll Achieve.

Ensure batches comply with specifications; Ensure batches comply with regulatory requirements

Industry & Context.

Healthcare
Problems you'll solve

Problem solving; Decision making

Eligibility Requirements

10-25% travel, 8-12 hour shifts

What They're Looking For.

Must Have

Bachelor's degree in relevant field, 3+ years pharmaceutical manufacturing QA, QA oversight of contract manufacturers

Nice to Have

ASQ Certified, Facility or area start up experience, Experience with gene therapy processes, Experience with Manufacturing Execution Systems, Technical writing experience, Ability to train and mentor others

What You'll Do.

Provide quality oversight of contract manufacturers

Manage daily contract manufacturing activities

Ensure adherence to Lilly GQS

Ensure adherence to cGMPs

Manage deviation investigations

Manage change control

Support inspection readiness

Support product launches

Accountable for batch disposition

Confirm batches comply with specifications

Confirm batches comply with regulatory requirements

Provide quality support of manufacturing operations

Review and approve procedures

Review and approve master production records

Review and approve change control proposals

Review and approve deviations

Review and approve equipment qualifications

Review and approve analytical methods

Review and approve computerized system validations

Provide onsite support of manufacturing operations

Participate in regulatory inspection preparations

Provide on-site support during inspections

Participate in APR activities

Participate in Post Launch Optimization Teams

How You'll Work.

Team & Collaboration

Cross-functional teams; Alliance partners; Contract manufacturers; Internal customers

Communication Scope

Oral communication; Written communication

Process & Methodology

Quality System, Validation

Full Job Description

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 around the world work 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 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 and 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 design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily co

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