QA Associate I — GMP Compliance & Process Improvement

ProQuality Network; Kentucky; On-site; USD 55,000 - 75,000; Full time

Job summary

ProQuality Network in Kentucky seeks a QA Associate I to provide quality support for solid oral dosage manufacturing, ensuring compliance with cGMP, CFR, and company SOPs through review of batch records, in-process testing, and real-time monitoring.

Responsibilities include SOP/batch record reviews, real-time audits, environmental monitoring, investigations, deviation reports in TrackWise, and training of manufacturing staff; requires a Bachelor’s or HS with experience.

Qualifications

• Bachelor’s degree preferred with 2+ years of relevant experience.
• Minimum high school diploma with 4+ years of GMP manufacturing experience.
• Familiar with cGMP, CFR and SOPs and able to support QA investigations.

Responsibilities

• Review SOPs and batch records for accuracy and compliance.
• Perform real-time audits of batch records and monitor critical process parameters.
• Conduct environmental monitoring and room/equipment clearances.
• Support deviation investigations and prepare problem reports in TrackWise.
• Assist in training manufacturing staff and promoting GMP compliance.

Skills

SOPs

cGMP

Quality assurance

Documentation

Environmental monitoring

TrackWise

CAPA

Investigations

Data collection

Education

Bachelor's degree

HS diploma + 4+ years GMP experience

Tools

TrackWise

JD Edwards

MS Office

Job description

ProQuality Network in Kentucky seeks a QA Associate I to provide quality support for solid oral dosage manufacturing, ensuring compliance with cGMP, CFR, and company SOPs through review of batch records, in-process testing, and real-time monitoring.

Responsibilities include SOP/batch record reviews, real-time audits, environmental monitoring, investigations, deviation reports in TrackWise, and training of manufacturing staff; requires a Bachelor’s or HS with experience.