Senior QA Lead – GLP/QMS, CAPA & Compliance

OpAns LLC; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

A leading research organization is seeking a Mid-Senior Quality Assurance Manager to support the development of new drugs through expert analysis of biological specimens. This role entails managing audits, authoring SOPs, and ensuring compliance with quality management systems. The ideal candidate should possess strong communication and organizational skills and have a background in regulatory environments. The position offers a competitive salary ranging from $110,000 to $140,000 annually.

Qualifications

• Strong background in audits and quality management in a laboratory setting.
• Excellent written and verbal communication with command of English.
• Ability to work effectively in a fast-paced environment.

Responsibilities

• Provide advanced analysis of biological specimens for drug development.
• Maintain and monitor quality management system documents.
• Prepare for and host regulatory inspections.

Skills

Audit performance

Standard operating procedures (SOP) authoring

Regulatory compliance

Communication skills

Problem solving

Organizational skills

Data analysis software

Conflict resolution

Tools

Agilent MassHunter

Job description

A leading research organization is seeking a Mid-Senior Quality Assurance Manager to support the development of new drugs through expert analysis of biological specimens. This role entails managing audits, authoring SOPs, and ensuring compliance with quality management systems. The ideal candidate should possess strong communication and organizational skills and have a background in regulatory environments. The position offers a competitive salary ranging from $110,000 to $140,000 annually.