Quality Assurance Representative - Parenteral

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.

Responsibilities:

The Quality Assurance Representative for the Parenteral team (preparation, formulation, filling, visual inspection) provides oversight daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, sterility assurance, aseptic behavior, commissioning, and qualification activities. A key member of the production process teams and coordinates support with the process team leaders. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for pre-approval/general inspections by various regulatory agencies. 

• Support the site in the development and execution of the site readiness plan with focus on supporting development fill operations process and startup of new systems.
• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).
• Active on local process teams or indirect participation through project support activities
• Lead, mentor, and coach operations and support personnel on quality matters.
• Ability to assess and triage deviations / observations that occur within Drug product filling and visual inspection processes.
• Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function.
• As applicable, approve commissioning qualification / validation documents for equipment to ensure compliance with quality standards.
• Liaison 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.
• Responsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.

Basic Requirements:

• Bachelor’s or equivalent (Science or Engineering related degree preferred).
• Minimum of 5 years of demonstrated experience in GMP facility.

Additional Skills/Preferences:

• Demonstrate knowledge and understanding of aseptic manufacturing process, isolator technology, visual inspection, and Quality Systems.
• Ability to make technical decisions, provide guidance to the site and lead others.
• Demonstrated strong oral and written communication skills, interpersonal skills and ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous regulatory inspection readiness and inspection execution experience.
• Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS), Deviation Management Systems (TrackWise), Change Management.
• CQA certification from the American Society for Quality (ASQ) or CSQA Experience
• Proficiency with computer systems including Microsoft office products.
• Proven ability to work independently or as part of a team to resolve issues.

Additional Information:

• Support for 24/7 manufacturing operation.
• Flexible working environment with the ability to work remotely 2 – 4 days a month.

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 complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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