Qa Specialist 2, Batch Release Contractor

Prokidney

Winston, United States
On-site
Maintain accurate gmp database tracking
Review batch and material release documentation
Evaluate manufacturing records for compliance
ProKidney is seeking a QA Specialist 2 for their Winston, United States location. The role focuses on Quality Assurance support in a GMP-regulated environment, primarily involving batch and material release activities

Job Summary

  • The QA Specialist 2 provides essential Quality Assurance support to Quality Operations with a primary focus on material and batch release activities.
  • The successful candidate applies developing professional knowledge and strong attention to detail to support documentation, compliance monitoring, and quality system activities.
  • Candidates must be eligible to work in the United States without the need for work visa or residency sponsorship.

Matching Summary

Match Score: 85

ProKidney is seeking a QA Specialist 2 for their Winston, United States location. The role focuses on Quality Assurance support in a GMP-regulated environment, primarily involving batch and material release activities.

Skills & Requirements

Must-have

  • Maintain accurate GMP database tracking
  • Review batch and material release documentation
  • Evaluate manufacturing records for compliance
  • Monitor production activities for non-compliance
  • Assist in deviation investigations and CAPA

Nice-to-have

  • Experience with electronic batch record systems
  • Familiarity with FDA, EU, or ISO frameworks
  • Proficiency with Microsoft Word and Excel
  • Strong verbal and written communication skills
  • Participation in internal and external audits

Key Requirements

  • Associate's Degree + relevant experience OR Bachelor's in Life Sciences + 2 years experience
  • Working knowledge of GMP and cGxP regulations
  • Eligible to work in the US without sponsorship

Work Rights

Must be eligible to work in the US without sponsorship

Tailored Resume

Cover Letter