Environmental QA Specialist – GMP Monitoring & Compliance

ProQuality Network; Juncos (PR); Hybrid; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

ProQuality Network in Juncos, PR is seeking experienced QA professionals to support the Environmental Monitoring Program in a regulated pharmaceutical manufacturing environment. The selected candidates will perform critical QA activities to ensure cGMP compliance and robust environmental controls.

Ideal candidates bring microbiology, data trending, and contamination control expertise, with knowledge of FDA/ISO standards.

Qualifikationen

• Experience supporting GMP Environmental Monitoring in a regulated pharma manufacturing environment.
• Strong knowledge of microbiology, contamination control, and data trending.
• Familiarity with regulatory requirements (FDA, ISO 14644, USP) and quality systems.

Aufgaben

• Support GMP Environmental Monitoring processes across AML site facilities.
• Generate Environmental Monitoring and Critical Utilities trend reports.
• Participate in risk assessments for routine monitoring locations.
• Lead investigations and site audits as needed.
• Collaborate to ensure QMS compliance and support audits.

Kenntnisse

Environmental Monitoring

Microbiology

Data trending

Regulatory compliance

QA processes

Ausbildung

Master’s degree in Life Sciences

Bachelor’s degree in Life Sciences

Associate degree in related field

High School Diploma/GED

Tools

LIMS

Veeva

Spotfire

Smartsheet

Microsoft Office

Jobbeschreibung

ProQuality Network in Juncos, PR is seeking experienced QA professionals to support the Environmental Monitoring Program in a regulated pharmaceutical manufacturing environment. The selected candidates will perform critical QA activities to ensure cGMP compliance and robust environmental controls.

Ideal candidates bring microbiology, data trending, and contamination control expertise, with knowledge of FDA/ISO standards.