Pharma QA Leader: SPC-Driven Quality & Compliance

Prinston Laboratories; Charlotte (NC); On-site; USD 130,000 - 160,000; Full time

Job summary

Prinston Laboratories seeks a Quality Assurance Manager for its pharmaceutical oral solid dosage facility in Charlotte, NC. You will oversee the Site Quality Management System, ensure cGMP compliance, manage document control, training, and market vigilance to maintain inspection readiness.

You will lead batch review and disposition, COA/CoC reviews, and CAPA programs, while driving risk-based investigations and continuous improvement across QA operations.

Qualifications

• Bachelor’s degree in a scientific discipline with advanced degree preferred.
• Minimum 6+ years of progressive QA/QMS experience in QA or related roles.
• Experience with cGMP, FDA regulations, and regulatory inspections.
• Strong knowledge of QMS, documents, data integrity, and CAPA processes.
• Proven ability to lead cross-functional projects and teams.

Responsibilities

• Oversee QA/QMS activities, SPC, APQR and QMR data analysis to support leadership decisions.
• Lead batch review, disposition, COA/CoC reviews and final batch release under applicable regulations.
• manage investigations for quality events, deviations and customer complaints using RCA.
• Define and implement CAPA, risk management, and compliance improvements.
• Maintain document control lifecycle and data integrity across the site.

Skills

Leadership

Communication

Analytical thinking

Project management

Cross-functional teams

Risk-based decisions

Time management

Quality assurance

Education

B.S. in Chemistry/Pharmacy/Engineering

Tools

TrackWise

Veeva Vault

MasterControl

SAP

Microsoft Office

Job description

Prinston Laboratories seeks a Quality Assurance Manager for its pharmaceutical oral solid dosage facility in Charlotte, NC. You will oversee the Site Quality Management System, ensure cGMP compliance, manage document control, training, and market vigilance to maintain inspection readiness.

You will lead batch review and disposition, COA/CoC reviews, and CAPA programs, while driving risk-based investigations and continuous improvement across QA operations.