Essential Functions/Responsibilities

- Support and assist with the management and maintenance of the site-wide quality program, including     GLP/GCLP/ISO9001/CLIA requirements for preclinical and clinical operations, as applicable.

- Conduct routine internal audits of the animal vivarium and in-vitro laboratories
- Oversee and manage document control in EQMS
- Assist with the site training program.
- Provide support for internal/external complaint and deviation investigations.
- Support study directors to develop Corrective Action Preventive Action (CAPA) plans.
- Support the various site continued improvement efforts.
- Lead site internal audits to ensure compliance to QMS
- Support client audit and supplier qualification program.
- Represent QAU on the site EHS (Environment, Health and Safety) team
- Monitor site key performance indicator (KPI) and provide reports for management review 
- Actively contribute to the success of the overall QA team and the site as a whole.

Minimum Requirements

- Requires a Bachelor degree in a technical field, or equivalent combination of academic and work experience.
- Requires 3+ years of auditing and document control experience in a GLP/GCLP and/or CLIA environment
- Able to make informed decisions based on a review of analytical data
- Able to comunicate in a clear, coherent and concise manner (verbal and written communication)
- Willing and able to work independently and in a team environment to efficiently meet assigned timelines
- Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and Internet
- Excellent interporsonal, organizational and time-management skills
- Able to multi-task with a high degree of professionalism and diplomacy.

Preferred Requirements

- Laboratory working experience in GLP/GCLP/CLIA environment is preferred
- Experience working with an EHS is team preferred
- Experience with AAALAC/IACUC is preferred
- Experience with Veeva Vault e-QMS and IDBS ELN systems is preferred