Quality Assurance Associate Job at Intellectt Inc, Richmond, KY

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  • Intellectt Inc
  • Richmond, KY

Job Description

Hello,

One of my clients is currently looking for a QA Associate I – Biotechnology Industry. If you're interested or if your skills align with the role, please share your updated resume or get in touch with me directly.

Job Title: QA Associate I – Biotechnology Industry

Location: Richmond, KY

Type: Contract (Approx. 6 Months)

Shifts: Candidates must be available for all shifts; final assignment is based on operational needs:

  • Friday – Sunday

Position Overview

We are seeking a detail-oriented QA Associate I to support Quality Assurance operations in a GMP-regulated pharmaceutical manufacturing environment . This role ensures real-time compliance with FDA regulations, internal procedures, and industry best practices during the production of solid oral dosage forms.

Key Responsibilities

  • Monitor manufacturing activities for compliance with cGMP and internal standards
  • Review and audit batch records in real-time for accuracy and completeness
  • Support and revise SOPs and documentation
  • Conduct in-process and finished product testing (e.g., particle size , bulk density , moisture , appearance , AQL )
  • Perform environmental monitoring (equipment and surface swabbing)
  • Clear rooms and equipment post-cleaning per procedures
  • Investigate and resolve production issues to prevent deviations
  • Initiate and document deviations in TrackWise
  • Manage inventory status in JD Edwards
  • Train manufacturing personnel on cGMP and proper documentation practices
  • Support CAPAs , root cause analysis , and customer complaint investigations
  • Promote cross-functional communication and teamwork

Qualifications

Preferred:

  • Bachelor’s degree in a science or technical field
  • 2+ years in a GMP-regulated manufacturing environment

Minimum:

  • High school diploma with 4+ years of relevant experience

Additional Skills:

  • Strong understanding of GMP , SOPs , and pharmaceutical manufacturing
  • Familiarity with TrackWise , JD Edwards , and quality documentation
  • Certifications such as Lean Six Sigma or ASQ are a plus

Job Tags

Contract work, Shift work, Sunday, All shifts,

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