QA Auditor II
On-siteRichmond, Virginia, United States
Richmond, Virginia, United StatesOn-siteFull TimeBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Conduct and lead client, internal, and GxP audits, including directed site, facility, vendor, and sub-contractor reviews. Provide GxP consultation and support to project teams and external clients while preparing audit findings for departmental and client meetings. Lead process audits and participate as a co-auditor in complex system audits, database audits, and clinical study report reviews. Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter. Perform root cause analysis and process improvement activities to ensure regulatory compliance and quality standards.
Required Qualifications
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Thorough knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
- Excellent oral and written communication skills
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Above average negotiation and conflict management skills
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Ability to perform under stress
- Ability to multi-task
- Regular and consistent attendance
- Ability to work in an upright and/or stationary position for 6-8 hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Frequent mobility required
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
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