Remote QA Auditor - Pharma & GxP Compliance

Altasciences; Olyphant (Lackawanna County); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance

401(k) with Employer Match

Paid Vacation & Holidays

Paid Sick & Bereavement Leave

Employee Assistance & Telehealth

Telework when applicable

Job summary

Altasciences is seeking a QA Auditor to join our team in the United States. The role reports to the QA Supervisor and conducts systematic audits of trial-related activities and documents to verify adherence to protocols, SOPs, GxPs, and regulatory requirements.

Responsibilities include preparing inspection reports, communicating findings, and guiding process improvements while maintaining QA records and collaborating with cross-functional teams.

Qualifications

• Bachelor degree or higher in Chemistry, Biochemistry, Biology, or equivalent field.
• Equivalent combination of education and experience in the pharmaceutical industry.

Responsibilities

• Audits phases of laboratory and clinical studies, reports, and related duties to ensure regulatory compliance.
• Audits all disciplines (e.g., Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Writes and issues inspection reports and communicates findings to internal clients; evaluates responses to findings.
• Ensures SOPs are current and practiced across studies.
• Identifies opportunities for process improvement and participates in cross-department efforts.
• Maintains QA records and study files.

Education

Bachelor degree or higher in Chemistry, Biochemistry, Biology, or equivalent field

Job description

Altasciences is seeking a QA Auditor to join our team in the United States. The role reports to the QA Supervisor and conducts systematic audits of trial-related activities and documents to verify adherence to protocols, SOPs, GxPs, and regulatory requirements.

Responsibilities include preparing inspection reports, communicating findings, and guiding process improvements while maintaining QA records and collaborating with cross-functional teams.