PPD QA Auditor II - Vaccine Sciences Lab Quality Assurance Team in Richmond, Virginia
QA Auditor II - Vaccine Sciences Labs Team
Location: Richmond, VA
Position: Full time salaried position with benefits.
The QA Auditor II conducts complex 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 issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
The QA Auditor II may also perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.
Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
Performs directed site audits, facility, vendor and/or sub-contractor audits
Provides GxP consultation and support to PPD project teams and external clients
Leads process audits and may participate as a co-auditor in more complex system audits
Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Serves as a resources to operational departments on audit or quality assurance subject matter
Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Education and Experience:
Bachelor's degree in laboratory sciences or related field
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience.
Successful completion of PPD Foundation Training
Knowledge, Skills and Abilities:
Experience with quality auditing and review for lab operations
Experience with vaccine sciences, bioanalytical sciences or related preferred
Experience in a GLP regulated environment preferred
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.
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.
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.
*Job: Lab Operations
*Organization: Richmond Lab-United States (LBRUS)
*Title: QA Auditor II - Vaccine Sciences Lab Quality Assurance Team
*Requisition ID: 145521