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Quality Assurance Specialist

2 months ago

Noblesville, United States Yoh, A Day & Zimmermann Company Full time

Yoh is seeking a Quality Assurance Specialist for our pharmaceutical client in Noblesville, Indiana.


Pay: $30-$36/hr

Hours: M-F, 8:00 am - 4:30 pm

Type: Contract


Summary of Position

The Quality Assurance Specialist position is responsible for product oversight, material release, technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment.


Essential Functions

  • Review and edit documents for accuracy, completeness, and consistency.
  • Perform QA on the Floor function.
  • Gown into a grade C and D environment.
  • Monitor aseptic operations for Quality Assurance.
  • Review batch record completeness for accuracy and compliance.
  • Review and release incoming materials for accuracy and compliance.
  • Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.
  • Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).
  • Support regulatory and client audits.
  • Conducts internal audits of the QMS and sub systems.
  • Analyze data to identify areas for improvement in the quality system.
  • Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).


Education Requirements

  • Bachelor Degree in Science or related field required.
  • 3 or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance
  • Knowledge of tools, concepts and methodologies of Quality.
  • Auditing experience, along with deviation and lot release support.