Kelly Science, Engineering, Technology & Telecom · 4 weeks ago
Clinical Quality Assurance Specialist
Kelly Science, Engineering, Technology & Telecom is seeking a Clinical Quality Assurance Specialist to administer routine QA activities related to data and report review in the Clinical Department. The role involves reviewing clinical reports for accuracy, assisting with the controlled document system, and ensuring compliance with Good Clinical Practice guidelines.
Staffing & Recruiting
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
Qualification
Required
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
Benefits
Robust benefits package including, health, dental and vision.
401(k) matching.
Opportunities to progress and develop your career including global opportunities for suitable candidates.
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.