Quality Control Specialist, GMP/GLP (Multi-Site)

ProQuality Network; United States; Hybrid; USD 60,000 - 85,000; Full time

Job summary

ProQuality Network is seeking a Quality Control Specialist (Regulated Industry) to support laboratory operations in a highly regulated environment. The role emphasizes complex technical challenges and data analysis within molecular biology and microbiology labs.

The position focuses on laboratory compliance, technical troubleshooting, and continuous improvement of quality processes, with collaboration across multi-site teams and interaction with regulatory agencies as needed.

Qualifications

• Advanced technical and scientific writing capabilities; able to analyze data and report findings.
• Experience in pharmaceutical or regulated industry; knowledge of GMP and CFR.

Responsibilities

• Provide technical guidance, reports, and data analysis to cross-functional teams.
• Investigate, troubleshoot, and resolve technical issues related to laboratory assays and testing methods.
• Ensure laboratory compliance with GMP, GLP, and safety standards by implementing and improving procedures.
• Manage existing programs and support development and implementation of new processes and quality initiatives.
• Develop, revise, and audit complex controlled documentation that may impact multiple sites.
• Review and approve laboratory investigations and support or lead audit activities.
• Serve as SME and assist in developing technical training programs.

Skills

GMP compliance

Quality analysis

Technical writing

Cross-functional collaboration

Regulatory knowledge

Data analysis

Education

Doctorate in a relevant scientific field

Master’s degree + 2 years of related experience

Bachelor’s degree + 4 years of related experience

Associate’s degree + 8 years of related experience

High School Diploma/GED + 10 years of related experience

Tools

Excel

Computer system validation

Method validation

QA software

Job description

ProQuality Network is seeking a Quality Control Specialist (Regulated Industry) to support laboratory operations in a highly regulated environment. The role emphasizes complex technical challenges and data analysis within molecular biology and microbiology labs.

The position focuses on laboratory compliance, technical troubleshooting, and continuous improvement of quality processes, with collaboration across multi-site teams and interaction with regulatory agencies as needed.