Clinical Quality Assurance Specialist
About the role
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 QA Director on special projects. This position is based in Phoenix, AZ however some travel may be required on occasion (
Responsibilities
- Review of raw data and associated clinical reports for accuracy and compliance.
- Final report review and QA release.
- Aid in the administration of the controlled document system, including standard operating procedures, protocols, forms, and supporting documents.
- Aid in the maintenance of archives of completed clinical notebooks, study files and master documents, including interactions with external archival storage facilities, as necessary.
- Aid in the setup of new employees.
- Review / approval of Deviations, Corrective / Preventive Action (CAPA) proposals and other quality related requests as assigned.
- Aid in 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.
- Aid in special projects as assigned.
Requirements
- Lifescience 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.
- Multitasking and team player.
- Organized, detail oriented, competent, and responsible.
- Good technical writing and communication skills.
Qualifications
- 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.
Skills
- Strong organizational and attention to detail skills.
- Ability to work independently and as part of a team.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office Suite.
Benefits
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
Pay
$27-$ 33/hr + benefits
Schedule
Full-time
Benefits
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.