QA Representative - Secondary Loop

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.
The Indianapolis Parenteral Manufacturing organization is located in Indianapolis, IN and provides various parenteral products for patients around the world. The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored, and maintained. The Secondary Loop QA Rep in Parenteral Manufacturing is a key member that can work effectively cross-functionally, is engaged, proactive, and provides support and guidance to Floor Support staff to achieve the reliable and compliant manufacture of parenteral drug product. The Secondary Loop QA Rep position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
Responsibilities:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Lead, support, mentor, and coach primary QA loop representatives.
• Support personnel on quality matters.
• Ensure regular presence in operational areas to monitor GMP programs and quality systems.
• Interact with process teams by representing the Quality function to support improvement and productivity objectives including development and implementation of process improvement, including capital expansions and technical projects.
• Ability to assess and triage deviations that occur within the local process teams.
• Work with Lilly support groups and external partners to resolve or provide advice on product related issues.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.
• Lead and / or support project and process improvement initiatives for Plant Process Teams as representative of the Quality function.
• Author, review, or approve documents, including control strategies, investigations, change controls, validations, qualifications, procedures, technical studies, etc. to ensure quality attributes are met and compliance with quality standards
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Network with Global Parenteral Network sites as resources and benchmarking sources.

Basic Qualifications:

• Bachelors or equivalent (Science or Engineering related degree preferred).
• Demonstrated equivalent experience in a GMP facility preferred.
• Proficiency with computer systems including Microsoft Office products.
• Good written and oral communication and interpersonal skills.
• Knowledge and understanding of manufacturing process and Quality Systems.
• Strong technical writing, decision making and problem-solving skills.
• Ability to work independently or as part of a team to resolve an issue.

Additional Skills/Preferences

• Demonstrated relevant experience in a GMP facility.
• Knowledge of parenteral manufacturing and aseptic manufacturing practices.
• Proven ability to work cross-functionally, implement projects, and build relationships.
• Proficiency with local computer systems including QualityDocs (Veeva), TrackWise, PMX, and Darwin.

Additional Information

• Day Shift, possible off - shift support may be required.
• This position will be in Indianapolis, but could require some travel, less than 10%, including international.
• Tasks require entering manufacturing areas which require wearing appropriate PPE.
• This position is tech ladder approved.

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