Clinical Quality Assurance (QA) Auditor Job

Yoh has a long term contract opportunity for a CLINICAL QUALITY ASSURANCE (QA) AUDITOR to join our client, a world leader in the healthcare industry, located in Ridgefield, CT.

JOB RESPONSIBILITIES:

- Manage trial audit programs to determine the number of audits to occur globally and follow these assignments to ensure the audits are occurring per plan
- Responsible for maintaining and updating CTM
- Responsible for conducting on site audits and assist in internal system audits
- Participate in special project teams, such as inspection readiness activities
- Responsible to create a global audit program for a trial and interact with the project manager to convey quality concerns
- Responsible for setting up a global audit plan and tracking the global audit results, analysing the results to determine if additional waves of audits are required

JOB QUALIFICATIONS:

- Bachelors Degree
- Five to eight (5-8) years experience in Pharmaceutical or CRO
- Prefer candidates with prior site auditing experience, but will also consider candidates who have functioned as a Sr. CRA
- Must fully understand the site process to include:
- Good Clinical Practices/FDA Regulations (Canadian regulations are a plus)
- Medical Record/electronic medical records
- Facility standards (archiving, laboratory, pharmacy, calibration/maintenance, etc.)
- Understanding of medical terminology and various disease states
- Source Document Verification/eCRFs
- Drug accountability
- Ability to access overall quality of Investigator Sites participating in Clinical Trials
- Experience in MS Office

PLEASE NOTE CANDIDATES CAN WORK REMOTE BUT WILL NEED TO BE ONSITE FIRST 3 MONTHS AND WILL NEED TO COME ONSITE 1 WEEK PER QUARTER. MUST BE WILLING TO TRAVEL UP TO 45% TO CONDUCT AUDITS (MOSTLY DOMESTIC, BUT INTERNATIONALLY AS WELL)

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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