Conduct QA audits such as database audits, clinical study report audits, sample results tables, etc.
Serve as a knowledgeable resource on audit or quality assurance subject matter
Prepare and present audit findings and/or other related information to Operations staff and SMEs.
Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.