Clinical Quality Assurance Specialist

ALS • Phoenix, AZ

1d • Onsite

About The Position

ALS has an excellent opportunity for a Clinical Quality Assurance Specialist. The Clinical QA Specialist administers routine QA activities directly related to data, and final report, review and approval in the Clinical Department. The Clinical QA Specialist assists the Clinical Quality Assurance department and ALS QA Director on special projects. This position is based at our ALS Clinical office in Phoenix, AZ however some travel may be required to the other clinical sites (5-10% travel). This full time position will report directly to the Quality Assurance Director. The Clinical QA Specialist may also work closely with the Clinical Director to ensure the research studies are conducted under company SOP’s and to Good Clinical Practice guidelines.

Requirements

• Life Science Bachelor’s Degree (Biology, Chemistry)
• 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.

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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees