QA Floor Support Associate

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

Position Description:

The QA Floor Associate is responsible for QA oversight on the floor of all GMP Manufacturing processes. This role involves conduction real time quality inspections and collaborating with the production team to understand and resolve quality concerns immediately on the floor. The QA Floor Associate is essential for maintaining GMP compliance and providing support to Parenteral Manufacturing.

Key Objectives /Deliverables:

• Ensure regular presence in operational areas to monitor GMP programs and quality systems including various production activities such as drug product formulation, equipment preparation and aseptic filling activity.
• Review batch records in real time to ensure adherence to standard operation procedures.
• Collaborate closely with process teams to resolve quality issues and operational support.
• Review and approve GMP documentation including procedures, deviations, technical reports, equipment cycle/alarm reports, change controls, logbooks etc.
• Ability to complete gowning qualification.
• Support inspection readiness activities.
• Ensure data integrity by design.
• Identify improvements/new procedures/compliance gaps based on applicable regulations for GMP operations.
• Audit critical manufacturing processes to ensure cGMP compliance and approve critical manufacturing areas for use.
• Identify and respond to instances of manufacturing deviations and discrepancies; assess risk to product and provide recommendations to management for resolution.
• Monitor, generate, and review daily alarm reports within the Environmental
• Monitoring System to ensure compliance with GMP regulations.

Additional Preferences:

• Ability to work independently or as part of a team to resolve issues
• Strong attention to detail and ability to make decisions in support of quality and compliance within the manufacturing environment
• Experience in GMP production environments is desirable (operations, QA)
• Proficiency with computer systems including Microsoft Office products, TrackWise, Blue Mountain, MasterControl, Siemens environmental monitoring, and SAP
• Demonstrate strong oral and written communication and interpersonal skills
• Demonstrated decision making and problem-solving skills
• Demonstrate knowledge and understanding of manufacturing process and Quality Systems
• Demonstrate technical writing and communication skills
• Experience with CAPA implementation and root cause investigations

Education:

• Bachelor's degree in science or equivalent experience.
• 3 years of relevant experience. Pharmaceutical preferred.

Other Information:

• Night shift
• Ability to work overtime as required.
• 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.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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