Onsite Plant QA Specialist - GMP & Quality Leadership

SSi People; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading quality assurance firm located in North Carolina is seeking a Sr. Associate in Plant Quality Assurance (PQA) to provide crucial oversight during drug substance manufacturing. This role entails ensuring compliance with GMP and quality standards while collaborating with manufacturing teams to address any quality-related issues. Ideal candidates will have a background in manufacturing and PQA, and experience within GMP-regulated environments. This position is fully onsite, emphasizing teamwork and real-time quality decision-making.

Qualifications

• Manufacturing and Plant Quality Assurance (PQA) experience is essential.
• Drug Substance manufacturing experience preferred.
• Experience with batch records, deviations, and QA oversight is required.

Responsibilities

• Provide on-the-floor PQA support and GMP oversight for manufacturing operations.
• Review and approve batch records, deviations, investigations, and CAPAs.
• Ensure adherence to cGMP, GDP, and internal quality procedures.
• Support audits, inspections, and regulatory interactions as needed.

Skills

Manufacturing and Plant Quality Assurance (PQA) experience

Ability to work independently

Experience with batch records

Previous experience in GMP-regulated facilities

Job description

A leading quality assurance firm located in North Carolina is seeking a Sr. Associate in Plant Quality Assurance (PQA) to provide crucial oversight during drug substance manufacturing. This role entails ensuring compliance with GMP and quality standards while collaborating with manufacturing teams to address any quality-related issues. Ideal candidates will have a background in manufacturing and PQA, and experience within GMP-regulated environments. This position is fully onsite, emphasizing teamwork and real-time quality decision-making.