Lead Technician - QA - Floor Support - Night Shift jobs in United States
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Eli Lilly and Company · 5 hours ago

Lead Technician - QA - Floor Support - Night Shift

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The QA Floor Support Lead Technician is responsible for providing daily support and oversight to GMP operations, ensuring quality compliance and safety within the manufacturing environment.

BiotechnologyHealth CareMedicalPharmaceutical
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Responsibilities

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)

Qualification

GMP experienceQuality Assurance oversightTrackWise proficiencyMicrosoft Office proficiencyVeeva Vault experienceInterpersonal skillsOrganizational skillsAttention to detailCommunication skills

Required

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
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role

Preferred

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

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

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We're a medicine company turning science into healing to make life better for people around the world.

Funding

Current Stage
Public Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase