Regulated QC Specialist - GMP/GLP Lab Lead (Onsite, 6 Mo)

ProQuality Network; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to provide technical leadership in molecular biology and microbiology testing within a GMP/GxP regulated environment.

The role requires collaboration across departments and sites, with responsibilities including testing development, equipment validation, documentation, and regulatory interactions. Onsite contract position with cross-functional team leadership.

Qualifications

• Must have extensive experience in regulated laboratory environments.
• Proficient in laboratory testing and validation activities.
• Strong technical writing and documentation skills.
• Ability to lead cross-functional teams and manage complex projects.

Responsibilities

• Provide technical guidance and SME for laboratory testing and development.
• Prepare technical reports, data analysis, and documentation for cross-team use.
• Troubleshoot and resolve laboratory assay and analytical testing issues.
• Ensure GMP, GLP, and safety regulatory compliance in operations.
• Develop and improve laboratory programs, processes, and methodologies.
• Review and audit complex controlled documentation across sites.

Skills

Technical leadership

Laboratory support

GMP/GLP knowledge

Laboratory analytics

Education

Engineering (Chemical/Environmental/Mechanical/Electrical)

Chemistry or Biology degree + Equipment Validation

Tools

Equipment Validation

Job description

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to provide technical leadership in molecular biology and microbiology testing within a GMP/GxP regulated environment.

The role requires collaboration across departments and sites, with responsibilities including testing development, equipment validation, documentation, and regulatory interactions. Onsite contract position with cross-functional team leadership.