Onsite QA Specialist — GMP Compliance & Validation

ProQuality Network; United States; Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance (QA) Specialist to support quality systems and regulatory compliance in a cGMP environment. This onsite role in the East Region, Puerto Rico, is contracted for approximately 9 months with 1 opening.

The candidate will oversee QA processes across manufacturing, validation, change control, and product release, ensuring strict documentation and regulatory alignment.

Qualifications

• Master’s degree with 2 years of directly related experience, or Bachelor’s with 4 years, or Associate’s with 8 years, or High School Diploma/GED with 10 years.
• Experience in GMP-regulated environment with manufacturing and process validation.
• Experience with New Product Introduction (NPI), Change Control, FATs, Validation, PPQs.
• Strong project management and cross‑functional leadership.

Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative in incident triage teams.
• Approve Environmental Characterization reports and planned incidents.
• Support the release of sanitary utility systems.
• Represent Quality Assurance in NPI project teams.
• Lead investigations and participate in site audits.
• Act as designee for the QA Manager during local CCRB meetings.
• Review and assess Risk Assessments, Change Controls, and CAPA records.
• Review and approve Work Orders, EMS/BMS alarms, and NC investigations.

Skills

Project management

Cross-functional leadership

QA/QAL experience

GMP compliance

Documentation control

Regulatory liaison

Quality investigations

Education

Master’s degree w/ 2 years

Bachelor’s degree w/ 4 years

Associate’s degree w/ 8 years

High School Diploma/GED w/ 10 years

Tools

Microsoft Office

Database

Presentation tools

Job description

ProQuality Network is seeking a Quality Assurance (QA) Specialist to support quality systems and regulatory compliance in a cGMP environment. This onsite role in the East Region, Puerto Rico, is contracted for approximately 9 months with 1 opening.

The candidate will oversee QA processes across manufacturing, validation, change control, and product release, ensuring strict documentation and regulatory alignment.