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Job #03142

About our client Our client is an international CRO that provides complete clinical trials management support for diverse therapeutic areas, such as oncology, cardiology and medical devices. Their vision is to become the preferred CRO for life science companies across the world. This is a great opportunity for someone looking for growth and an exciting challenge. Position Location Senior Quality Assurance Auditor Ryebrook, New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the management with overall quality, compliance and auditing activities 2) Ensure compliance of operations with corporate policies, industry standards and applicable regulations by conducting audits of internal files, clinical sites and vendors used to support clinical trials 3) Support organization’s GCP mentoring and compliance by ensuring quality activities are performed and documented in compliance with SOPs, company guidelines and applicable regulations 4) Coordinate and conduct clinical site audits as per company SOPs and GCP regulations 5) Conduct and coordinate vendor as well as potential business partner audits 6) Carry out trial master file, process and system audits to verify compliance with regulations, SOPs and guidelines 7) Conduct on-going audits to assess company employees’ compliance with internal SOPs, sponsor requirements and all applicable regulations (local, federal and international) 8) Develop audit plans and provide reports for various internal and external audits, ensuring development and tracking of appropriate corrective action plans 9) Follow-up with individual departments on audit findings and corrective action plans 10) Assist with completion of sponsor audit surveys and vendor assessments 11) Perform client QA reviews 12) Assist and host sponsor and regulatory agency audits 13) Perform selected QA reviews of company policies, procedures and deliverables 14) Review and author departmental quality documents (SOPs), working instructions, templates and audit checklists and make recommendations for process improvements 15) Audit regulatory submissions for quality, consistency, accuracy, content and format 16) Assist with corporate validation initiatives and the documentation of validation efforts to meet FDA compliance requirements (as applicable) 17) Review project and corporate validation documentation for adequacy, completeness and compliance with quality system requirements 18) Assist staff in resolving quality systems issues 19) Attend project meetings and special topic committees as compliance representative and assist as a Quality/Compliance Advisor 20) Assist Manager with departmental activities and act as Manager backup (as required) 21) Provide supervision, guidance and training on regulations and compliance 22) Assist with other corporate QA and compliance efforts 23) Perform all other duties as assigned Requirements 1) BS in Life Sciences or equivalent degree 2) Minimum 5 years of working experience within the clinical, regulatory or quality environment (pharmaceutical/biotech/CRO) 3) Minimum 2 years of experience in clinical site monitoring, GCP quality assurance auditing and GCP regulations 4) Experience in presenting conclusions in a clear and concise manner 5) Computer Systems Validation (CSV) experience a plus 6) Knowledge of local, state and federal regulations pertaining to GCPs, ICH guidelines and HIPAA requirements 7) Good understanding of drug, biologics and device clinical trial development processes 8) Excellent organizational skills with the ability to be logical, systematic and curious 9) Superb communication skills (verbal and written) 10) Excellent interpersonal skills 11) Proficiency in MS Office (MS Word, Excel, and Power Point) and other common software applications as well as navigating the Internet 12) Ability to work in a high-volume environment with strict deadlines 13) Ability to gather and interpret relevant information 14) Ability to work independently and maintain confidentiality 15) Ability to be a team player