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
