Quality Assurance Specialist

2 hours ago


Indianapolis, Indiana, United States Genezen Full time
Job Title: Quality Operations Associate

Genezen is seeking a highly skilled Quality Operations Associate to join our team. As a Quality Operations Associate, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Provide quality oversight and expertise to operations, manufacturing, and quality control activities.
  • Ensure compliance with GMP, SOP, and regulatory requirements.
  • Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
  • Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
  • Assist in the final disposition of master cell banks and viral vector products.
  • Provide site GMP and GDP training (annually, for new-hires, and as needed).
  • Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions.
  • Drive Quality Events to closure within on-time closure deadlines.
Requirements:
  • Bachelor's degree in science or related field.
  • Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials.
  • Familiarity of eQMS systems such as Veeva.
  • 3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role.
  • Experience working in with early phase clinical trial production and testing.
What We Offer:
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
  • Employer-paid basic term life/personal accident insurance.
  • Voluntary disability, universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.

Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.



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