QA Auditor

About the Role

The QA Auditor reports to the QA Supervisor. This individual is responsible for carrying out systematic and independent examination (i.e., audit) of multiple trial‑related activities and documents, to determine whether the evaluated trial‑related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GxPs and the applicable regulatory requirements. They are responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). They will also be responsible for building and maintaining effective working relationships throughout the organization.

Responsibilities

• Audit phases of laboratory and clinical studies, report, and perform related duties (e.g., issue findings and QA statements) to ensure regulatory compliance.
• Audit all disciplines (examples include Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services).
• Perform in‑life audits, process audits, vendor qualifications, equipment and software validation audits.
• Write and issue inspection reports.
• Work with internal clients to ensure that inspection findings are clearly communicated and understood.
• Evaluate inspection finding responses to ensure they address the findings appropriately.
• Ensure through phase and data inspections that the SOPs involved in the conduct of a study are current and practiced.
• Identify and communicate opportunities for process improvement based on audit and inspection observations.
• Participate in and guide process improvement activities in both small intradepartmental groups and complex, multi‑department interactions.
• Maintain necessary documentation of QA records and study files.
• Notify management of observed quality and compliance trends in the areas inspected.
• Under supervision of a mentor/coach, perform tasks such as SOP QA review, client hosting, regulatory agency hosting, and external test site/clinical site/bioanalytical laboratory qualifications.
• Recommend modifications in procedures to fit special needs or problems and involve the manager when assistance in process improvement/resolution is necessary.
• Interpret GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process‑improvement recommendations.
• Prepare for RQAP‑GCP and/or RQAP‑GLP certification.
• Carry out appropriate self‑development efforts as directed.

Requirements

• Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, or an equivalent field, or an equivalent combination of education and experience in the pharmaceutical industry.
• Legal authorization to work in the United States; Altasciences cannot provide sponsorship, sponsorship transfers, or visa maintenance for this position. Applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

Benefits

Altasciences offers a wide variety of benefits to help employees live healthy and fulfilling lives both at and outside of work.

• Health, dental, and vision insurance plans
• 401(k)/RRSP with employer match
• Paid vacation and holidays
• Paid sick and bereavement leave
• Employee assistance and telehealth programs
• Telework when applicable
• Training and development programs
• Employee referral bonus program