QA Auditor

Altasciences; Scranton (Lackawanna County); Presencial; USD 70 000 - 95 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Auditing

Regulatory compliance

GxP knowledge

Documentation

Formação académica

Bachelor's degree in Chemistry/Biochemistry/Biology

Descrição da oferta de emprego

Altasciences seeks a QA Auditor to conduct systematic audits of clinical and laboratory trial activities, documents, and processes. The role ensures regulatory compliance with protocols, SOPs, and GxP requirements, reporting findings to study teams and management while identifying improvement opportunities.

Responsibilities

• Audit laboratory and clinical study phases, reports, and related documentation 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

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, or equivalent field
• Equivalent combination of education and pharmaceutical industry experience
• Legal work authorization in the United States; no sponsorship available
• Knowledge of GCP, GLP, and GCLP regulatory requirements
• Ability to conduct audits across multiple disciplines and study phases