Quality Assurance Representative - Parenteral Operations Support
Location: Indianapolis, Indiana, United States
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job ID: R-80282
Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, headquartered in Indianapolis, Indiana, we work to discover and deliver life-changing medicines to those who need them. Our employees are dedicated to improving disease management and giving back to communities through philanthropy and volunteerism.
Compensation:
Actual compensation depends on education, experience, skills, and geographic location.
Anticipated wage: $63,000 - $162,800
Position Overview:
The QA Representative for manufacturing floor support at the Indianapolis Parenteral Manufacturing site provides daily oversight, assistance, and guidance on non-conformance investigations, change control proposals, procedure/master formula revisions, validations, batch disposition, commissioning, and qualification activities. This role ensures GMP compliance and provides support during Pre-Approval/General Inspections by regulatory agencies.
Responsibilities:
Ensure adherence to safety rules and maintain a safe work environment.
Lead, mentor, and coach operations and support personnel on quality matters.
Maintain regular presence in operational areas to monitor GMP programs and quality systems.
Actively participate in the local process team as outlined in MSOE standards or through project support.
Assess and triage deviations within the local process team.
Collaborate with 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.
Review/redline documents to ensure quality attributes are met (deviations, procedures, technical studies, validation protocols, change controls, and engineering documents).
Contribute to Lean initiatives to improve productivity within the local process team or quality organization.
Support project and process improvement initiatives for Plant Process Teams as a Quality representative.
Approve commissioning, qualification, and validation documents for computer systems and equipment.
Network with Global Parenteral Network sites for benchmarking and resources.
Basic Requirements:
Minimum of a Bachelor's Degree in pharmaceutical sciences, biology, or engineering.
3+ years of experience in a function supporting parenteral operations.
Additional Skills/Preferences:
Experience in GMP production environments or Quality Assurance.
Knowledge and understanding of manufacturing processes and Quality Systems.
Experience with Deviation/Event, Root Cause Investigation, and Change Management processes.
Ability to work independently and as part of a team.
Strong critical thinking and compliance understanding.
Strong oral and written communication and interpersonal skills.
Technical writing and communication skills.
Demonstrated decision-making and problem-solving skills.
Strong attention to detail.
Proficiency with computer systems including Microsoft Office, TrackWise, PMX, and SAP.
Additional Information:
Overtime may be required.
May be required to respond to operational issues outside of core business hours.
Work may be conducted in various areas within the Parenteral Plant, with possible exposure to allergens.
Equal Opportunity Employer:
Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Employee Resource Groups (ERGs):
Lilly supports diverse networks to develop talented individuals for future leadership roles. Groups include:
African American Network
Early Career Professionals
PRIDE (LGBTQ+ Allies)
Veterans Leadership Network
Women’s Network
Working and Living with Disabilities
Benefits:
Eligible employees have access to a company-sponsored 401(k), pension, medical, dental, vision, and prescription drug benefits. Additional benefits include:
Flexible spending accounts
Life insurance
Time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits)
#WeAreLilly
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