Quality Assurance Auditor - Clinical & Lab Compliance

121 Altasciences Preclinical Scranton, Inc

Scranton (Lackawanna County)

On-site

USD 55,000 - 90,000

Full time

4 days ago
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Benefits offered by this job

Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth
Telework when applicable

Job summary

Altasciences is seeking a Quality Assurance Associate to safeguard clinical and laboratory research, ensuring studies meet GxP and regulatory standards. You will work across Clinical Operations, Laboratory Services, Data Management, Recruiting, and more to support quality initiatives and drive continuous improvement.

You will review study documentation, participate in audits, and help develop corrective actions while collaborating with cross-functional teams.

Qualifications

  • Bachelor's degree in a scientific discipline (Biology, Chemistry, etc.)
  • Familiarity with regulated quality systems (GCP/GLP/GCLP) preferred
  • Strong documentation and audit-reporting abilities

Responsibilities

  • Conduct audits of clinical and laboratory activities for protocol and SOP compliance.
  • Review study documentation and data for accuracy and completeness.
  • Collaborate with Clinical Operations, Laboratory Services, Data Management, and other teams to support quality initiatives.
  • Prepare clear audit and inspection reports and lead corrective action development.

Skills

Quality assurance
Regulatory awareness
Auditing
Documentation
Communication

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Life Sciences, Pharmaceutical Sciences, or related

Tools

MasterControl
Watson LIMS
Analyst software

Job description

Altasciences is seeking a Quality Assurance Associate to safeguard clinical and laboratory research, ensuring studies meet GxP and regulatory standards. You will work across Clinical Operations, Laboratory Services, Data Management, Recruiting, and more to support quality initiatives and drive continuous improvement.

You will review study documentation, participate in audits, and help develop corrective actions while collaborating with cross-functional teams.

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