QA Auditor I or QA Auditor II

Pharmaceutical Product Development (PPD)

VA-Richmond


Title: QA Auditor I - Labs or QA Auditor II

Department: Quality Assurance supporting Vaccine Sciences

Location: Richmond, Virginia

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a QA Auditor I or QA Auditor II you will assure the quality of lab data and reports.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose: 

Assures the quality of lab data and reports. Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies and addresses non-conformance issues. Assists in the delivery of quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects. Applies company policies and procedures to resolve routine issues.

Essential Functions:   Audits laboratory data for compliance with methods and standard operating procedures and report findings Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings Serves as a resource to operational departments on audit or quality assurance subject matter Assists in the preparation of audit findings and/or other related information

Title: QA Auditor I - Labs or QA Auditor II

Department: Quality Assurance supporting Vaccine Sciences

Location: Richmond, Virginia

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As a QA Auditor I or QA Auditor II you will assure the quality of lab data and reports.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose: 

Assures the quality of lab data and reports. Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies and addresses non-conformance issues. Assists in the delivery of quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects. Applies company policies and procedures to resolve routine issues.

Essential Functions:   Audits laboratory data for compliance with methods and standard operating procedures and report findings Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings Serves as a resource to operational departments on audit or quality assurance subject matter Assists in the preparation of audit findings and/or other related information

Education and Experience: 

QA Auditor I- Labs: Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience.

QA Auditor II: 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.

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 Associate QA plus: Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines) Thorough working knowledge of SOPs and WPDs Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) Strong attention to detail Able to work independently or in a team environment Good problem-solving abilities Good organizational and time management skills Basic computer skills and ability to learn and become proficient with appropriate software Proven flexibility and adaptability

Working Environment: 

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, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

Education and Experience: 

QA Auditor I- Labs: Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience.

QA Auditor II: 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.

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 Associate QA plus: Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines) Thorough working knowledge of SOPs and WPDs Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) Strong attention to detail Able to work independently or in a team environment Good problem-solving abilities Good organizational and time management skills Basic computer skills and ability to learn and become proficient with appropriate software Proven flexibility and adaptability

Working Environment: 

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, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  


2020-08-08 00:00:00


Apply to this job