QA Auditor II or III

Title: Quality Assurance Auditor II or QA Auditor III

Division / Dept.: Quality Assurance and Compliance

Location: Richmond, VA (Office Based)

Notes: Full time, Benefits, Immediate Opening

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

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

PPD offers continued career advancement as a Quality Assurance Auditoras well as management and specialized opportunities in other departments within PPD.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

As a QA Auditor II or QA Auditor II, you will: Conduct 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.Identify issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.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.

Title: Quality Assurance Auditor II or QA Auditor III

Division / Dept.: Quality Assurance and Compliance

Location: Richmond, VA (Office Based)

Notes: Full time, Benefits, Immediate Opening

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

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

PPD offers continued career advancement as a Quality Assurance Auditoras well as management and specialized opportunities in other departments within PPD.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

As a QA Auditor II or QA Auditor II, you will: Conduct 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.Identify issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.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 (biology, microbiology, or forensic science major preferred)Previous experience in quality assurance andstatistical experience required2 years' experience for QA Auditor II5 years' experience for QA Auditor III

Knowledge, Skills and Abilities: 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 load

PPD 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 and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Education and Experience: Bachelor's degree (biology, microbiology, or forensic science major preferred)Previous experience in quality assurance andstatistical experience required2 years' experience for QA Auditor II5 years' experience for QA Auditor III

Knowledge, Skills and Abilities: 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 load

PPD 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 and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.