Quality Auditor, Scientific – Pharma QA & Compliance

Primary Talent Partners, LLC

Elkhorn Precinct (NE)

On-site

USD 28,000 - 35,000

Full time

7 days ago
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Job summary

Primary Talent Partners is seeking a Quality Auditor - Scientific - I (Assistant) for a 12-month contract in Elkhorn, NE. The role focuses on reviewing production batch documents, batch records, and supporting QA with compliance activities in a GMP environment.

You will work in a primarily office setting with time in manufacturing areas, coordinating with IPTs and QA leadership to ensure timely releases and documentation quality.

Qualifications

  • HS Diploma with at least 3 years of work history.
  • HS Diploma with 1 year of experience in similar industry.
  • Degree in microbiology, chemistry, or similar scientific discipline.
  • Familiarity with vaccine manufacturing/testing and USDA/FDA regulations.

Responsibilities

  • Review completed production batch documents.
  • Batch record review.
  • Provide documentation guidance from a quality compliance perspective.
  • Track and prioritize document reviews to meet target dates.
  • Communicate status to groups downstream and upstream.
  • Assist with document archival tasks.
  • Support QA inspections, investigations and compliance actions.
  • Work in a clean manufacturing lab environment with time in manufacturing areas.
  • Back-up QA functions and quality systems tasks.
  • Develop competency across QA functions.
  • Participate in quality compliance inspections and other tasks as assigned.

Skills

Quality Assurance
Document review
Regulatory compliance
GMP

Education

HS Diploma
Degree in microbiology

Tools

SAP

Job description

Primary Talent Partners is seeking a Quality Auditor - Scientific - I (Assistant) for a 12-month contract in Elkhorn, NE. The role focuses on reviewing production batch documents, batch records, and supporting QA with compliance activities in a GMP environment.

You will work in a primarily office setting with time in manufacturing areas, coordinating with IPTs and QA leadership to ensure timely releases and documentation quality.

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