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Lilly Associate-QC EM/Fume in Indianapolis, Indiana

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 35,000 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.

Position Brand Description:

The EM/FUME Associate assists in the safe, compliant execution of the environmental monitoring program for the Indianapolis Parenteral Manufacturing production areas. The EM/FUME Associate is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, acting as a liaison between EM and multiple areas in execution of improvements, projects, change controls, and assisting in providing coverage in the absence of area leadership.

Key Objectives / Deliverables:

  • Safety – Ensures that all safety procedures, policies, permits and practices are followed. Leads and/or participates in incident investigations, near miss reviews and notifications. Be an active participant in safety improvements and reduction of risk/incidents.

  • Quality – Ensures processes meet the quality standards as defined by cGMPs, Global Quality Standards, local procedures and production tickets (as applicable). Escalates concerns, investigates problems, conducts root cause and implements appropriate corrective or preventative actions.

  • Maintain Process Execution – Develops and maintains understanding of environmental monitoring and utility monitoring in a Parenteral manufacturing facility. Acts as liaison with multiple teams (e.g. Operations, Sterility Assurance, Quality Assurance). Maintains a regular presence on the production floor. Serves as SME or power user in MODA (data system).

  • Operational Excellence – Drives and supports continuous improvement through data collection, evaluation and effective implementation of solutions using Lilly change management process. Will learn and leverage Lilly CCI (Lean), OSSCE and CAPA programs to identify, implement and sustain improvements.

  • Other - capable of functioning as back up to leadership when necessary.

Minimum Requirements:

  • Demonstrated ability to effectively communicate with both written and verbal multi-level in the organization

  • Demonstrated ability to design and implement change in a regulated environment

  • Demonstrated ability to prioritize, set objectives and meet targets

  • Demonstrated ability to work without close supervision

  • Demonstrated ability to understand data and adjust actions (flexibility)

  • Demonstrated proficiency with computer systems and multiple software applications including Microsoft Office products

  • Demonstrated excellence in teamwork and interpersonal skills

  • Relevant experience in a GMP facility

Additional Preferences:

  • Experience in parenteral manufacturing operations

  • Degree in science related field

Education Requirements:

  • Bachelors Degree or minimum 7 years of aseptic/environmental monitoring experience

Other Information:

  • Position supports a 24/7 operation and is expected to be flexible in maintaining availability for support in decision making and issue resolution as necessary to support operations of the facility.

  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

  • Position is day shift, minimal travel required.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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