Job Details

What You’ll Do:
* Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
* Perform directed site audits, facility, vendor and/or sub-contractor audits
* Provide GxP consultation and support to project teams and external clients
* Lead process audits and may participate as a co-auditor in more complex system audits
* Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
* Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
* Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Education and Experience:
* 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’).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
* 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
* Flexible and able to multi-task and prioritize competing demands/work load
* Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Conditions and Environment:
* Work is performed in an office/ laboratory and/or a clinical environment.
* Exposure to biological fluids with potential exposure to infectious organisms.
* Exposure to electrical office equipment.
* Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:
* 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.
* 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.
* Frequently interacts with others to obtain or relate information to diverse groups.
* Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
* Regular and consistent attendance.