To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03488

About our client Our client is a mid-size pharma company focused on the development and commercialization of therapeutics that address unmet medical needs. They currently have one product on the market and one drug candidate that they have submitted to the FDA for market approval in addition to a robust pipeline. The company has strong financials, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate! Position Location Clinical QA Auditor Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Review clinical trials data for consistency, completeness, and timelines in preparation for statistical analysis. Communicate with clinical trials management staff to resolve discrepancies in data, request clarification and secure incomplete data items. 2) Perform audits of Clinical Protocols, Investigator Brochures, Study Reports (e.g. CSR, ISS and ISE), Clinical Investigational Sites, IRBs, CROs as well as other vendors, as assigned to assure compliance with study procedures and regulatory standards. 3) Conduct QA audits of Table, Listing and Figure to assure compliance with study procedures and regulatory standards. 4) Provide QA reviews of validation reports and documents while ensuring compliance to the standards of Good Documentation Practices, GCP and 21 CFR Part 11. 5) Effectively and accurately document audit findings by generating an audit report, or other Quality Assurance summaries and obtain responses in a timely fashion. 6) Evaluate audit responses for compliance with applicable guidelines, regulations, and Standard Operating Procedures/Policies. Obtain remediation when responses are unacceptable. 7) Follow up on corrective and preventive actions to ensure continuing effectiveness. 8) Create and maintains audit files for CQA Department. 9) Provide departments with industry updates by use of internet, publications, references, etc. 10) Conduct internal audits with regards to documentation and compliance. (e.g. Trial Master File, electronic files, etc.) 11) Participate in Project Team Meetings as applicable. 12) Assist with hosting regulatory agency inspections. 13) Author and review Standard Operating Procedures, as applicable. 14) Provide Training relative to GCP and Compliance, as applicable, assist in the development of training materials. 15) Maintain Trending information as a result of all audits performed. 16) Additional tasks as assigned by the Clinical Quality Assurance Management. Requirements 1) Bachelor's degree. 2) 5+ years of Quality Assurance experience within a clinical research or Sponsor organization. 3) 4+ years Clinical GCP QA auditing experience. 4) Auditing training/experience (e.g., CQA& Compliance or similar type training and/or extensive auditing experience in a GCP environment). 5) Intensive knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit procedures and reporting. 6) Some knowledge of GLP and or GMP regulations. 7) Thorough knowledge of current and pending FDA regulations, 21CFR, and ICH Guidelines/EU Directives.