QA Auditor: GxP Compliance & Process Improvement

Altasciences; Scranton (Lackawanna County); On-site; USD 70,000 - 95,000; Full time

Job summary

Altasciences seeks a QA Auditor to conduct systematic audits of clinical and laboratory trial activities, documents, and processes to ensure regulatory compliance with protocols, SOPs and GxP requirements. You will report findings to study teams and management while identifying opportunities for improvement.

Responsibilities include auditing laboratory and clinical study phases, writing inspection reports, and maintaining QA records.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, or related field.
• Equivalent combination of education and pharmaceutical industry experience.
• Knowledge of GCP, GLP, and GCLP regulatory requirements.

Responsibilities

• Audit laboratory and clinical study documents for regulatory compliance.
• Conduct in-life audits, process audits, vendor qualifications, and equipment validation audits.
• Write and issue inspection reports; communicate findings clearly to internal clients and evaluate responses.
• Identify process improvement opportunities based on audit observations and participate in improvement initiatives.
• Maintain QA records and study files; notify management of quality and compliance trends.

Skills

Auditing

Regulatory compliance

GxP knowledge

Documentation

Education

Bachelor's degree in Chemistry/Biochemistry/Biology

Job description

Altasciences seeks a QA Auditor to conduct systematic audits of clinical and laboratory trial activities, documents, and processes to ensure regulatory compliance with protocols, SOPs and GxP requirements. You will report findings to study teams and management while identifying opportunities for improvement.

Responsibilities include auditing laboratory and clinical study phases, writing inspection reports, and maintaining QA records.