Quality Assurance Auditor III - Home Based with 25-30% Travel
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 (Information Systems) team helps our clients ensure the integrity of their clinical trials.
A Quality Assurance Auditor III - SDLC (software development life cycle) provides expertise to the QA department and serve as the primary audit and oversight function of PPD's regulated computer validation activities and related services. 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. Serve as the primary audit and oversight function for PPD's regulated computer validation activities and related services.
As a Quality Assurance (QA) Auditor III - SDLC (software development life cycle) with PPD's Global Quality and Compliance (Information Systems) team, you will:
- Provide expertise to the QA department and serve as the primary audit and oversight function of PPD's regulated software development, computer system validation activities and related Information Technology (IT) services.
- Conduct complex internal and/or external system audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines (e.g., electronic records and electronic signatures) and/or client contractual obligations.
- Perform select assessments of study-specific builds to ensure compliance with established procedures within Clinical Data Management, IVRS and Central Labs.
- Identify issues impacting the quality and/or integrity of clinical research programs, 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 clinical development programs.
- Provide audit reports to management.
- Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.
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 5+ years’) or equivalent combination of education, training, & experience.
- Successful completion of PPD Foundation Training.
Knowledge, Skills and Abilities:
- Meets competencies for QA Auditor II plus:
- 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.
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.