Quality Assurance Specialist II

4 weeks ago


Morrisville, United States Innova Solutions Full time
Job Title: Quality Associate II

About the Role:
The Quality Associate II will contribute to the oversight of key strategic and operational aspects within Quality Assurance at the Client Research facility. Responsibilities include reviewing GMP raw data for compliance, performing duties in a manner consistent with site and corporate policies, and adhering to all regulatory licenses and regulations.

Key Responsibilities:
  • Review and approval of batch related documentation to support product disposition.
  • Transport batch related documentation across client buildings to support chain of custody and life cycle management.
  • Supports resolution of both technical and compliance issues/gaps of mild to moderate complexity.
  • Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance.
  • Complete and maintain related GMP training.

Requirements:
  • 0-2 years directly related to position responsibilities or biologic experience preferred.

Benefits:
Innova Solutions offers benefits (based on eligibility) that include medical and pharmacy coverage, dental and vision insurance, 401(k), health saving account (HSA), and flexible spending account (FSA).

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