Onsite QC Specialist Regulated Lab & Validation

ProQuality Network; United States; Hybrid; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to act as technical lead for testing in molecular biology and microbiology. The role focuses on complex issues across multiple sites and with outside resources, ensuring GMP and GLP compliance.

Responsibilities include guiding technical groups, data analysis, lab investigations, audits, and potential SME training. Strong communication and documentation skills are essential, with extensive knowledge of pharmaceutical

Qualifikationen

• Requires advanced knowledge of GMP, GLP and safety protocols.
• Proven ability to develop and audit complex controlled documents with multi-site impact.
• Extensive knowledge of pharmaceutical/biological testing and regulatory practices.

Aufgaben

• Provide technical guidance, reports and data analysis across multiple groups.
• Troubleshoot assays and resolve technical issues as needed.
• Ensure lab compliance and implement procedures to enhance GMP/GLP compliance and safety.
• Lead cross-functional teams and audit processes.
• Develop and supervise training and investigations as required.
• Interact with regulatory agencies when needed and manage multi-site action items.

Kenntnisse

GMP

Regulatory knowledge

Data analysis

Technical writing

Project management

Cross-functional teamwork

Troubleshooting

Quality systems

Communication

Auditing

Ausbildung

Doctorate

Master's + related experience

Bachelor's + related experience

Associates + related experience

High school/GED + 10 years experience

Jobbeschreibung

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to act as technical lead for testing in molecular biology and microbiology. The role focuses on complex issues across multiple sites and with outside resources, ensuring GMP and GLP compliance.

Responsibilities include guiding technical groups, data analysis, lab investigations, audits, and potential SME training. Strong communication and documentation skills are essential, with extensive knowledge of pharmaceutical