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

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