Job Description :

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

What You'll Do:
. Conduct and/or lead a variety of GxP qualification and routine vendor audits, as requested by senior management, including but not limited to on-site, virtual and remote audits of service providers used in clinical trials with or without technology components
. Perform directed vendor audits
. May perform clinical investigator site
. Provide GxP consultation and support to internal and external clients
. 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 and GxP vendor auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ 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:
. Solid knowledge of the clinical trial process

. Thorough knowledge of GxP and appropriate regional research regulations and guidelines
. Demonstrated proficiency and led a range of GxP vendor audits to high standards required by management
. Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)

. Strong attention to detail

. Effectively works independently or in a team environment
. Highly developed problem solving, risk assessment and impact analysis abilities
. Solid experience in root cause analysis and CAPA development
. Above average negotiation and conflict management skills
. Proven adaptability

. Strong organizational and time management skills including flexibility and ability to multi-task and prioritize competing demands/workload
. Strong computer skills ability to learn and become proficient in appropriate systems

. Fluent in English

. Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

The following is a plus:

. Experience performing other types of QA audits or activities (e.g., investigator site audits, database audits, clinical study report audits, sample results tables, process improvement)
. Experience hosting client audits and/or regulatory inspections.

. Experience delivering training.

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 may be 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

QA Auditor II (Vendor Auditor)