Clinical Quality Assurance Specialist

Overview

ALS is one of the world’s largest and most diversified testing and technical services providers with sites in more than 350 locations across 55 countries. Headquartered in Brisbane, Australia, ALS also has a Global Operations center in Houston, Texas.

The Clinical Quality Assurance Specialist administers routine QA activities related to data and final reports in the Clinical Department and assists the Clinical Quality Assurance department and ALS QA Director on special projects. The position is based at the ALS Clinical office in Phoenix, AZ and may require 5‑10% travel to other clinical sites. The full‑time role reports directly to the Quality Assurance Director and works closely with the Clinical Director to ensure research studies are conducted under company SOPs and Good Clinical Practice guidelines.

Shift: Full time, onsite, 40 hours a week, Monday to Friday – working hours 8:00 a.m. to 5:00 p.m.

• Review raw data and associated clinical reports for accuracy and compliance.
• Perform final report review and QA release.
• Assist with administration of the controlled document system (standard operating procedures, protocols, forms, and supporting documents).
• Maintain archives of completed clinical notebooks, study files, and master documents, including interactions with external archival storage facilities.
• Assist with new employee set‑up.
• Review and approve deviations, Corrective / Preventive Action (CAPA) proposals and other quality‑related requests as assigned.
• Assist with internal audits and follow‑up on recommendations and corrective actions.
• Ensure all procedures applicable to Clinical Operations are followed and perform all duties following current SOPs.
• Work with QA Management on special projects as assigned.

• Life Science Bachelor’s Degree (Biology, Chemistry) with a minimum of two (2) years of relevant experience in a clinical or quality‑oriented role, preferably within an FDA‑regulated industry.
• Experience in GMP and GCP.
• Reliable with a strong commitment to quality.
• Multi‑tasking and team player.
• Organized, detail oriented, competent, and responsible.
• Good technical writing and communication skills.

• Health Coverage:
  Medical, Dental, and Vision.
• Retirement Plan: 401(k) and Roth contributions with a company match after 6 months of employment.
• Paid Time Off, Vacation.
• Company paid Life Insurance.
• Company paid Short Term and Long Term Disability.
• Other:
  Ancillary benefits.

ALS is an equal opportunity employer committed to maintaining a workforce that reflects and affirms the diversity of our society. EOE AA Minority, Female, Veteran, Individuals with Disabilities.

ALS is a VEVRAA Federal Contractor.