QA Auditor I','148694','!*!Responsibilities:
Conducts internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
Identifies and addresses non-conformance issues.
Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects.
Applies company policies and procedures to resolve routine issues.','!*!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 1-2 years’) or equivalent combination of education, training, & experience.
Successful completion of PPD Foundation Training.
Knowledge, Skills and Abilities:
Meets competencies for Associate QA Auditor plus:
Detailed knowledge of GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH
guidelines and to all other standards or guidelines applicable to business-related requirements,
Demonstrated ability to independently review study documents for compliance with regulatory requirements or PPD procedures (e.g. Informed consents, protocols, CRFs, Source Document Templates, method validations, equipment qualifications)
Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
Very good problem solving, risk assessment and impact analysis abilities
Proficient at negotiation and conflict management
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 travelWorking 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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.','Quality Management Systems','North America-United States-Virginia-Richmond','','','false','','false','QA Auditor I