Eli Lilly and Company · 7 hours ago
Quality Systems Associate
Philadelphia, PA
Full-time
Onsite
Entry Level
$65K/yr - $148K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Quality Systems Associate will manage controlled documents, oversee quality management systems, and support audit preparations, ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Oversee the management of controlled documents throughout their lifecycle for GxP and non-GxP Operations
Establish and maintain document control workflows and work instructions (e.g., Veeva document routing guides)
Manage job descriptions for all Avid personnel to assure inspection readiness
Manage room support during audits or regulatory inspections, as required
Provide audit support during Site Self-inspection and external audits/inspections, including managing support rooms and ensuring timely responses
Manage the transfer of paper documents to paperless systems, as applicable
Provide user management of data management systems and provide quality support to users (e.g., Veeva)
Provide guidance on Good Quality Practices (GQP) and ensure adherence to regulatory requirements
Generate monthly quality performance metrics using Excel PivotTables to visualize and assure timely closure of outstanding quality actions
Lead document migration projects and implement digital transformation initiatives to streamline workflows and reduce manual processes
Support oversight of external manufacturing organizations (i.e., creating TrackWise records for external action tracking)
Support GxP training program updates in SuccessFactors, maintaining compliance with training requirements
Write or revise SOPs associated with document control or areas of responsibility
Assist in or conduct GxP investigations (e.g., complaints, deviations, CAPA, and effectiveness checks)
Collaborate with cross-functional teams to ensure audit readiness and continuous improvement of quality processes
Identify any improvement opportunity within responsible areas and provide action plans, as required
Other duties as assigned
Qualification
Required
Bachelor's degree
Minimum of 2 years of experience in Pharmaceutical Quality Assurance
Preferred
Demonstrate experience in quality metrics reporting and audit preparation
Have experience in Good Quality Practices
Strong knowledge of MS Word with form generation and password protected functionality
Strong knowledge of MS Excel (e.g. formula, pivot tables and macro functionality)
Detail-oriented, ability to work independently, highly motivated
Strong interpersonal, verbal and written communication skills
Ability to work with colleagues
Ability to work independently and escalate issues when necessary
Experience with TrackWise, Veeva, and SuccessFactors for document control and training compliance
Benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-23
Company data provided by crunchbase