Quality Assurance Specialist
On-site · Marlton, New Jersey, United States
Marlton, New Jersey, United StatesOn-siteFull TimeMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Quality Assurance Specialist position involves assisting the QA Director in reviewing documentation to ensure compliance with protocols, conducting quality control checks, tracking documentation errors, and preparing for audits including those from the FDA. Applicants should have at least a Bachelor's degree and extensive knowledge of clinical trial regulations including FDA, GCP, and HIPAA. A minimum of 3 years in a relevant Quality Assurance role is required.
Required Qualifications
- In depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials
- Knowledge of IRB requirements
- Knowledge of HIPAA Privacy Act and its application to clinical research
- 3 plus years in work related to Quality Assurance area in clinical research
Desired Qualifications
- Experience including external clinical/regulatory and document auditing desirable.
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