Quality Assurance Specialist

Quality Assurance Specialist Dr. Vince Clinical Research - 4.4 Overland Park, KS Job Details Full-time 1 day ago Benefits Health savings account Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Qualifications Report writing GxP Writing skills Compliance audits & assessments Clinic experience Quality assurance audits Clinical research compliance Bachelor's degree Attention to detail Quality audits Full Job Description

POSITION SUMMARY

As a Quality Assurance Specialist you will review and confirm procedures, track and follow up on commitments and participate in audits and investigations. Tracking Compliance metrics and overseeing vendor qualification and status.

KEY RESPONSIBILITIES

The role is client-facing and requires professional presentation and communication skills. Participates in audits, CAPA's, and investigations. Performs internal audits and effectiveness checks. Reviews SOP, job aids, and other documents for accuracy and completeness. Evaluate & determine current regulations related to Clinical Research against site SOP's and processes. Participates in Computer System Validation (CSV) efforts.

REQUIRED QUALIFICATIONS

3-5+ years experience in Quality. Previous auditing experience Good working knowledge of regulated environments. Trained on cGXP. Excellent communication skills & understanding of SOP/departmental processes. Excellent reporting writing skills & ability to adhere to strict timelines. Ability to travel (as needed) for audits

PREFERRED QUALIFICATIONS

Audit certifications Experience within a clinic, hospital, pharmaceutical, or similar type environment. Experience responding to audits by sponsors and government agencies. Computer System Validation experience. Experience with conducting and/or evaluating CAPA's and investigations. If you are a detail-oriented individual, enjoys working directly with staff from every department and has a passion for ensuring quality, we would love to hear from you. Apply now to join our team as a Quality Assurance Specialist.

Job Type:

Full-time Benefits:

401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Paid time off Vision insurance Ability to

Relocate:

Overland Park, KS 66212: Relocate before starting work (Required)

Work Location:

In person