Job Description

The Quality Assurance Associate (A-2) is responsible for assisting with the development, implementation and maintenance of a quality system to support bioanalytical lab operations. Assist with the development and execution of regulatory training for all employees and for training on quality assurance policies, programs, and initiatives. Ensure that documents are reviewed and processes conducted and carried out in accordance with company quality policies and procedures and are in compliance with GLP requirements. Responsible for writing and reviewing SOPs and quality documentation. Conduct in lab audits and review of protocol, raw data and report supporting regulatory studies. Assist with process and facility inspections.

MAJOR DUTIES AND RESPONSIBILITIES
1. Serve as a source of quality assurance and GLP guidance to functional departments.
2. Assist with QAU administration.
3. Participate in the maintenance of the document management system.
4. Assist QA unit with awareness of compliance issues.
5. Review site procedures and ensure consistency of content of standards with GLP requirements. Present recommendations and changes to management.
6. Conduct and report inspections of study specific procedures and processes.
7. Reviews study plans, SOPs, raw data, methods and study reports; ensures that no deviations from approved requirements were made without proper authorization/documentation and were performed in accordance with the GLP regulations (as applicable).
8. Assist with conduct and reporting of Process and Facility audits.
9. Assist with training in GLP for Bioanalytical personnel.
10. Participate in QA-Bioanalytical meetings.
11. Additional duties as required and assigned.

SKILLS/KNOWLEDGE ? Knowledge of FDA regulations relating to GLP. Knowledge of quality systems pertaining to contract research supporting Pharmaceutical industry and good documentation practices within a CRO, life science, pharmaceutical industry. ? Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems ? Highly organized; ability to prioritize and demonstrate attention to detail ? Be pro-active and demonstrate initiative ? Good team player and experience of dealing with complex tasks ? Excellent customer service skills and ability to deal with people at all levels ? Time-management skills are required, as well as the ability to handle multiple projects WORK EXPERIENCE REQUIREMENTS 2+ years working in a GLP environment; 1+ years in a quality assurance or related role EDUCATION REQUIREMENTS B.S. or M.S. degree with 2 + year industry (pharmaceutical or bio lab) experience