Clinical Research Quality Control Specialist

Clinical Product Quality Specialist

Kelly Science and Clinical is hiring for a temp-to-perm need for one of our clients who is a leading player in the clinical research field, dedicated to advancing medical science and improving patient outcomes.

Their Clinical Department is at the forefront of cutting-edge research. This role will play a pivotal role in ensuring the accuracy, compliance, and quality of our clinical data and reports.

Location : Phoenix, AZ

Position Type : Full-Time, Onsite 6-month contract with strong potential to convert to permanent staff with our client

Shift : Monday to Friday, 8 : 00 a.m. to 5 : 00 p.m. (Flexibility to start at 6 am depending on study needs is possible but will still work 8-hour shifts)

Reporting To : Quality Assurance Director

Position Summary : The Clinical QA Specialist is responsible for administering routine quality assurance activities directly related to data, final report review, and approval within the Clinical Department.

Additionally, this role will provide support to the Clinical Quality Assurance department and the QA Director on special projects.

Key Responsibilities :

• Review raw data and associated clinical reports for accuracy and compliance.
• Conduct final report reviews and ensure QA release.
• Assist in administering the controlled document system, including standard operating procedures, protocols, forms, and supporting documents.
• Support the maintenance of archives of completed clinical notebooks, study files, and master documents, including interactions with external archival storage facilities.
• Assist in the onboarding and training of new employees.
• Review and approve Deviations, Corrective / Preventive Action (CAPA) proposals, and other quality-related requests as assigned.
• Participate in internal audits and follow up with recommendations and corrective actions.
• Ensure strict adherence to procedures applicable to Clinical Operations and maintain compliance with current SOPs.
• Collaborate with QA Management on special projects as assigned.

Qualifications :

• Bachelor's Degree in Life Sciences (Biology, Chemistry) or a related field.
• 3 years of relevant experience in a clinical or quality-oriented role, preferably within an FDA regulated industry.
• Experience in Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Reliable with a strong commitment to quality.
• Exceptional multitasking skills and ability to work effectively within a team.
• Highly organized, detail-oriented, competent, and responsible.
• Strong technical writing and communication skills.

If you are a dedicated professional with a passion for maintaining the highest quality standards in clinical research, we encourage you to apply for this exciting opportunity.

Join us in our mission to advance medical science and make a positive impact on patient healthcare.