Quality Assurance Auditor III-151094
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose- to improve health.
PPD's Global Quality and Compliance department helps our clients ensure the integrity of their clinical trials.
A Quality Assurance Auditor III will be responsible for ensuring computer validation activities and PPDs use of electronic records are in compliance with internal policies, procedures, and applicable international regulations and guidelines.
This position offers our full benefits package as well as continued career advancement working from an office or from home within the Global Quality and Compliance department or other departments within PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.
As a Quality Assurance (QA) Auditor III with PPD's Global Quality and Compliance department, you will:
- Ensure computer validation activities and PPDs use of electronic records are in compliance with internal policies, procedures, and applicable international regulations and guidelines.
- Provide expertise to the QA department and serve as the primary audit and oversight function of PPD's regulated computer validation activities and related services.
- Identify issues impacting the quality and/or integrity of clinical research computer applications, determines root cause of non-conformance and develops strategies to address issues.
- May perform technical document review and other GxP practice activities in support of information system audit programs.
- Plan and deliver quality services for deliverables generated by Computer System Lifecycle Management procedures.
QualificationsEducation 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 5 years’) or equivalent combination of education, training, & experience.
- Successful completion of PPD Foundation Training.
- Meets competencies for QA Auditor II plus:
- Thorough knowledge of GxP and computer system validation regulations, including 21 CFR Part 11
- Demonstrated proficiency and understanding of computer system validation principles and GxP audits and vendor audits
- 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
- Work is performed in an office.
- Exposure to electrical office equipment.
- 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.