Technician - Process Quality Assurance Floor Support (Night Shift) at Eli Lilly and Company

Durham, North Carolina, United States

Eli Lilly and Company Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries

Requirements

  • High School Diploma or equivalent
  • Legally authorized to be employed in the United States (no sponsorship anticipated)
  • Completion of Post Offer Exam or Work Simulation if applicable
  • Ability to work overtime as requested
  • Ability to work night shift in a 24/7 operation

Responsibilities

  • Adhere to safety rules and maintain a safe work environment by supporting HSE corporate and site goals
  • Ensure training is completed and remains in compliance
  • Communicate with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues
  • Ensure adherence and understanding of good documentation practices and compliance with applicable procedures for Operations and Support personnel
  • Advise Operations and support personnel on quality matters while driving the site Quality culture
  • Ensure regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs, and quality systems
  • Review and approve GMP documentation in support of daily operations (e.g., electronic batch record logs, paper logbooks, cleaning, procedures versus performance)
  • Perform daily documented Quality Checks
  • Perform sample collection, inspection, and delivery to storage location and/or laboratory
  • Troubleshoot and provide QA systems support to reconcile issues in systems (e.g., SAP, Darwin LIMS, TrackWise, PMX)
  • Participate in self-led inspections and provide support during internal/external regulatory inspections
  • Work cross-functionally and collaboratively with all levels of the organization

Skills

Key technologies and capabilities for this role

GMPQuality AssuranceAseptic BehaviorsGood Documentation PracticesParenteral ManufacturingVisual InspectionHSEQA Oversight

Questions & Answers

Common questions about this position

What is the shift for this Technician position?

This is a Night Shift position.

What are the basic requirements to apply for this role?

Candidates need a High School Diploma or equivalent and must be legally authorized to work in the United States without sponsorship.

What does the company culture at Eli Lilly emphasize?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and focuses on giving best effort while fostering a quality culture.

Is this a remote position or does it require on-site work?

This is an on-site position at the Eli Lilly RTP facility in Raleigh-Durham, North Carolina, involving regular presence in assigned parenteral areas.

What experience or skills make a strong candidate for this QA Floor Support role?

Strong candidates have knowledge of GMP operations, good documentation practices, experience with quality systems like SAP, LIMS, and TrackWise, and the ability to work cross-functionally in parenteral manufacturing areas.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.
Potential construction delays in Indiana could affect GLP-1 drug production timelines.
Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.
Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.
FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.
Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.
Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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