QA Quality Assurance Specialist Bucks County Area PA / NJ

QA Specialist Bucks County, PA
Description:Assist in maintaining regulatory compliance subject to GCP and ICH requirements. Prepare reports as needed for documentation. Prepare presentations to be conducted if required for staff, or sponsors, etc. Audit documents prior to release to a client or the FDA including protocols, CRFs, Informed Consent Forms, Regulatory Documentation, Clinical and Statistical Reports, Clinical Operating Plans and company SOP?s. Conduct on-site audits of investigator files for compliance with FDA regulations, protocol adherence, ICH Guidelines, GCPs, Company/Sponsor SOP?s, CRF Agreement with corresponding source documentation and Drug Accountability. Audit in-house Master Files for compliance with FDA regulations, protocol adherence as well as company/Sponsors SOPs. Assist in SOP Preparation. Provide database Quality Control using key variables approved by Sponsor, in accordance with SOPs. Provide organized reports of findings.

Requirements:Competency in clinical and regulatory auditing, grammar and logic. Ability to set and meet goals. Thorough knowledge of Federal and State regulations and applicable guidelines. Computer literacy in Windows environment. Excellent interpersonal skills. Travel at approximately 25-35%.

Education:BS or MS in a life science, RN, or BSN.

Experience:

Minimum 3 years of clinical/quality assurance or regulatory experience, site audit experience, computer validation experience.


EMAIL RESUMES TO dave@davehands.com