Eli Lilly and Company · 2 days ago
Technician - Process Quality Assurance Floor Support (Night Shift)
Durham, NC
Full-time
Onsite
New Grad, Entry Level
$18.02/hr - $38.61/hrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Quality Assurance Floor Support Specialist will provide QA oversight to GMP operations, ensuring compliance and quality in the parenteral equipment preparation, formulation, filling, and visual inspection areas.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals
Responsible for ensuring training is completed and remains in compliance
Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues
Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel
Advise Operations and support personnel on quality matters, while driving the site Quality culture
Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems
Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance
Performs daily documented Quality Checks
Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory
Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX)
Participate in self-led inspections and provide support during internal / external regulatory inspections
Ability to work cross functionally and work collaboratively with all levels of the organization
Qualification
Required
High School Diploma or equivalent
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Completion of Post Offer Exam or Completion of Work Simulation if applicable
Ability to work overtime, as requested
Preferred
Demonstrated strong oral and written communication and interpersonal skills
Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems
Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)
Previous work with combination products or devices with experience with US/EU regulations and notified bodies
Previous experience in GMP production environments
Previous facility or area start up experience
Knowledge of Validation / Qualification activities
Demonstrated decision making and problem-solving skills
Strong attention to detail
Proven ability to work independently or as part of a team to resolve issues
Benefits
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
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.
Founded in 1876
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
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