Lead Technician - QA - Floor Support - Night Shift

Quality Assurance Floor Support Lead Technician (Night Shift)

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 Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The QA Floor Support Lead Technician works as a team member supporting multiple production functions, from operations to maintenance, to achieve site goals while providing Quality oversight and guidance.

Responsibilities include:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Provides daily presence in operational areas to:
• Monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel
• Monitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete.
• Review and approve GMP documentation in support of daily operations such as:
• Maintenance Action Plans
• Return to Service and Release of equipment, product, and area HOLDs
• Cycle Summary Reports for equipment
• Ticket Check - In
• Work Order assessments and issue resolution
• Release of Sanitization Agents and pH Adjusters
• Other documents as required.
• Provide guidance and assistance in identifying potential product quality impact and assessing if Observations are required.
• Performs observational requirements for Aseptic Process Simulation 14-Day Reads and supporting observation during formulation and fill related aseptic activities.
• Provide QA systems support to reconcile issues in multiple systems such as:
• LMS
• PMX
• TrackWise
• EDMS
• GMARS
• And other systems as required.
• Work within QA Lead Technician team to ensure all manufacturing areas receive QA support needed to maintain daily operations.
• Reviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions).

Basic requirements include:

• High School Diploma or equivalent
• Experience working in a GMP facility
• Experience with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.

Additional preferences include:

• Demonstrated relevant experience in a GMP facility
• Demonstrated strong interpersonal skills and the ability to work as a team
• Demonstrated organization skills
• Demonstrated ability to learn quickly and utilize new skills
• Proficiency with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.
• Night Shift schedule flexibility.
• 3+ years of parenteral manufacturing experience
• Strong oral and written communication and interpersonal skills
• Strong attention to detail
• Experience in Production QA, QC is desirable
• Experience with TrackWise/Veeva OneQMS Deviation and Change Management processes.

Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Manufacturing plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Maintain qualifications and certifications for access to all supported areas required of the position, including but not limited to aseptic gowning certification. May be subject to Post Offer Exam. Mandatory overtime may be required, planned and unplanned.

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 for further assistance.

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 $28.84 - $46.54.

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).