PPD Experienced GCP Quality Assurance (QA) Auditor - Home-Based - 50% Travel in Wilmington, North Carolina

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose- to improve health.

PPD's Quality and Enterprise Learning department helps our clients ensure the integrity of their clinical trials.

A Quality Assurance Auditor 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.

This position will travel approximately 50% in the US.

This position offers our full benefits package as well as continued career advancement working from an office or from home within the Quality and Enterprise Learning 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.

Summarized Purpose:

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. May 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.

Responsibilities:

* * 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 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’) or equivalent combination of education, training, & experience.

Successful completion of PPD Foundation Training.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Meets competencies for QA Auditor I 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

Management Role:

No management responsibility

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.

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: Quality Management Systems

*Organization: Corporate-United States (CORUS)

*Title: Experienced GCP Quality Assurance (QA) Auditor - Home-Based - 50% Travel

*Location: United States

*Requisition ID: 144799