Associate - Quality Assurance Representative

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $162,800

Organization Overview:

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.

The Quality Assurance Team assures patients worldwide of safe and efficacious drug products through effective quality oversight of Indianapolis Parenteral Operation activities. The QA Representative may be responsible for the review of batch records for compliance to GMP and the disposition of incoming materials, semi-finished and/or finished products. The representative member provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure/master formula revisions, validations, batch disposition, commissioning, and qualification activities. The QA Representative supports and/or drives issue resolution and process improvements as a content expert technical resource.

 The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.

Key Objectives/Deliverables:

• Perform batch review and disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP compliance) is released to the market.
• Lead, mentor and coach operations and support personnel on quality matters associated with batch review and disposition.
• Provide guidance and feedback to operational areas to ensure robust quality system application and GMP compliance.
• Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
• Effectively review/approve GMP documents to ensure quality attributes are met
• Participate in process improvement initiatives to improve safety, quality and/or productivity within the workcenter and/or site.
• Maintain safe work environment and support HSE goals

Basic Requirements:

• Bachelors degree in STEM discipline (science or engineering related preferred)
• 1+ year of experience in Quality Assurance

Additional Preferences:

• Relevant experience in a GMP facility and previous Quality Assurance experience preferred.
• Experience in visual inspection, parenteral or packaging operations.
• Proficiency with TrackWise, SAP, MES (PMX), Darwin
• Proven ability to work independently and as part of a team to resolve issues
• Root cause analysis and troubleshooting skills
• Experience with deviation and change management processes
• Previous experience in QA or QC
• Technical writing and communication skills
• Proficiency with computer systems
• Strong oral and written communication skills
• Strong interpersonal skills and the ability to work as a team
• Demonstrated attention to detail
• Experience in Lean operations leveraging a Daily Management System (e.g. visual management, KPI, daily huddles, six sigma)

Additional Information:

• Overtime may be required. May be required to respond to operational issues outside of core business hours/days.
• Work in various areas in Parenteral Plant. Some allergens are present. Mobility and potential exposure to allergens should be considered when applying
• Position is located on site in Indianapolis at the Lilly Technology Center – South.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complet