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ALS · 3 weeks ago

Clinical Quality Assurance Specialist

Phoenix, AZ

Full-time

Onsite

Entry, Mid Level

2+ years exp

ALS is one of the world’s largest testing and technical services providers, with a focus on life sciences, food, pharmaceutical, and minerals sectors. They are seeking a Clinical Quality Assurance Specialist to administer QA activities related to data and report review in the Clinical Department, while also assisting with special projects and ensuring compliance with SOPs and Good Clinical Practice guidelines.

Professional ServicesTest and Measurement

Responsibilities

Review of raw data and associated clinical reports for accuracy and compliance

Final report review and QA release

Assist with the administration of the controlled document system, including standard operating procedures, protocols, forms, and supporting documents

Assist with maintenance of archives of completed clinical notebooks, study files and master documents, including interactions with external archival storage facilities, as necessary

Assist with set-up of new employees

Perform review / approval of Deviations, Corrective / Preventive Action (CAPA) proposals and other quality related requests as assigned

Assist with internal audits as assigned and follow up with recommendations and corrective actions

Ensure all procedures applicable to Clinical Operations are followed

Perform all duties following current SOP’s

Work with QA Management on special projects as assigned