GCP Quality Assurance Auditor II/III/Principal

Company: PPD
Location: Philadelphia
Posted on: November 15, 2019

Job Description:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.The Audit Management department conducts internal process/system audits, vendor audits and investigator site audits.As a Quality Assurance Auditor II/III/Principal you will conduct complex internal and external audits ensuring compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.This position offers our full benefits package as well as continued career advancement working from home within the Global Quality and Compliance Corporate Quality 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.Essential Functions:Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior managementPerforms directed site audits, facility, vendor and/or sub-contractor auditsProvides GxP consultation and support to PPD project teams and external clientsLeads process audits and may participate as a co-auditor in more complex system auditsPerforms 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 matterPrepares and presents audit findings and/or other related information at departmental, internal operations or client meetingsLI-JN1Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious 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:Meets competencies for QA Auditor I plus:Thorough knowledge of GxP and appropriate regional research regulations and guidelinesDemonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by managementExcellent oral and written communication skillsStrong problem solving, risk assessment and impact analysis abilitiesSolid experience in root cause analysisAbove average negotiation and conflict management skillsFlexible and able to multi-task and prioritize competing demands/work loadValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelManagement Role:No management responsibilityPPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.This role requires independent travel up to 50%, inclusive of traveling in automobiles, airplanes, and trains.Job Quality Assurance and ComplianOrganization: PPDTitle: GCP Quality Assurance Auditor II/III/PrincipalLocation: PA-PhiladelphiaOther Locations: United StatesRequisition ID: 163245PPD is an affirmative action employer that values diversity as a strength fosters and 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

Keywords: PPD, Lower Merion , GCP Quality Assurance Auditor II/III/Principal, Accounting, Auditing , Philadelphia, Pennsylvania