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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The primary responsibilities of the QA Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of IDAP. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

Promote safety awareness
Remain current with individual training plan
Observe, promote, and follow requirements related to safety, quality, security, customer service, and GMPs
Provide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint management
Provide quality oversight and provide quality support for bringing new products into IDAP
Provide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Specialists floor decisions
Raise notification to management for departures of critical nature and assure issues are addressed
Assess gaps between local and corporate standards and facilitate remediation efforts actively working with support areas
Ensure area is always audit ready
Support project timelines assuring compliance with Quality expectations
Proactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team members
Possess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.
Actively assist in continuous improvements and efficiency projects
Provide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processes
Actively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participation
Provide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automation

Basic Qualifications:

Bachelor's Degree in STEM field required
1 or more years experience in a GMP environment preferred

Additional Skills/Preferences:

Previous experience in Quality Assurance or Engineering preferred
Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
Experience supporting computer systems (e.g. CSV, CSQ, IDS experience)
Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality Docs
Experience in conducting root cause investigations, and execution of change management, equipment qualification, and process validation
Ability to communicate effectively with customers to carry out requirements
Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve
Ability to influence team interactions and lead initiatives
Demonstrated strong oral and written communication and interpersonal skills
Demonstrated decision making and problem solving skills
Demonstrated knowledge and understanding of manufacturing process and Quality Systems
Demonstrated attention to detail
Demonstrated ability to coordinate and prioritize multiple tasks.

Additional Information:

Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs
Overtime and weekend work may be required.
Individual must be available via cell phone
Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Some travel may be required