Clinical QA Specialist

ALS LIMITED • Phoenix, AZ

77d • Onsite

About The Position

This full time, onsite position will report directly to the Quality Assurance Director in the Phoenix office. 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. The position is Monday to Friday, from 7:30 AM to 4:00 PM, but must also be flexible to work from 5:30 AM to 2:00 PM for sequestered clinical studies.

Requirements

• Life Science Bachelor's Degree (Biology, Chemistry) Minimum of six (3) years of relevant experience in a clinical or quality-oriented role, preferably within an FDA regulated industry.
• 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.
• 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

• Structured wage increases
• Comprehensive benefit package (including medical, dental, and vision coverage, life and disability insurance, retirement plan with company match, employee assistance and wellness programs, access to company perks)
• Additional vacation days for years of service
• Business support for education or training after 9 months with the company
• Learning & development opportunities (unlimited access to e-learnings and more)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees