Quality Assurance Specialist

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

Job Title: Sr. Associate, Plant Quality Assurance (PQA)

Location: North Carolina – Fully Onsite

ob Summary

The Sr. Associate, Plant Quality Assurance (PQA) provides on-the-floor quality oversight for bulk drug substance manufacturing and new product introductions. This role partners closely with Manufacturing to ensure real-time GMP decision-making, compliance, and continuous improvement within a regulated manufacturing environment.

Key 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 deviation management, change assessments, and quality event resolution
• Oversee compliance during manufacturing execution and on-the-floor analytical testing
• Review and approve SOPs and quality documentation
• Support audits, inspections, and regulatory interactions as needed
• Collaborate with Manufacturing to troubleshoot issues using a quality mindset

Required Qualifications

• Manufacturing and Plant Quality Assurance (PQA) experience
• Drug Substance manufacturing experience preferred
• Experience with batch records, deviations, and QA oversight
• Previous experience in GMP-regulated facilities (GMP/GNP)
• Ability to work independently, in teams, and across shifts

About SSi: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do, we have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.