Quality Assurance Associate Opening

JOB SUMMARY
The Quality Assurance Associate leads the definition, implementation, and maintenance of the Quality System and Quality Plan at the local iCS office and ensures compliance with applicable regulatory requirements. As needed, the Quality Assurance Manager assists the Corporate Director of Quality Assurance with tasks and activities in support of special QA projects or business needs.

DUTIES AND RESPONSIBILITIES
" Define, document, implement, and maintain the local Quality System and Quality Plan

" Ensure compliance of the Site with applicable regulatory requirements (e.g. contract research organization (CRO) requirements, etc.)

" Oversee SOP training compliance including maintenance of audit-ready training documentation.

" Prepare, review, approve, issue, and/or maintain Quality System documentation and procedures in accordance with relevant regulations.

" Assist the Corporate Director of QA in the management and conduct the internal and vendor audit programs

" Lead local audit readiness and preparation activities and plans

" In collaboration with the Corporate Director of QA, host local client audits and regulatory inspections

" Manage the local deviations and corrective action processes

" Provide guidance and interpretation of regulatory requirements for functional areas.

" Perform other QA duties as assigned

EDUCATION, TRAINING AND PRIOR EXPERIENCE REQUIREMENTS
Associate's Degree or commensurate education/experience.  Minimum of five years of experience working with Quality Systems and procedures, and previous QA audit experience.  Excellent organizational skills and attention to detail.  Ability to convey information concisely and clearly.  Excellent verbal and written communication skills in a professional manner.  Familiarity with international standards and guidance is desirable.  Previous management or supervisory experience is ideal.

All inVentiv Clinical employees have access to competitive medical and dental benefits, 401K and PTO. For any questions regarding this and other inVentiv Clinical opportunities, please email or call Amelia Barker; at ABarker@inVentivclinical.com or 610-644-7969.