QA Auditor II- Vaccines

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and life cycle 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 II you will conduct complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

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 well-being of our employees.  

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 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

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and life cycle 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 II you will conduct complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.

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 well-being of our employees.  

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 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.

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: Knowledge of immunochemistry (ELISA), functional assays, or statistics and FDA's GLP, GCLP (Good Clinical Laboratory Practices), or GMP (Good Manufacturing Practices) regulations are required. Good verbal and written communication skills are necessary. Must be detail oriented and able to deal with changing priorities.

Working Conditions: Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.

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 complex 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 Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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.

PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.

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.

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: Knowledge of immunochemistry (ELISA), functional assays, or statistics and FDA's GLP, GCLP (Good Clinical Laboratory Practices), or GMP (Good Manufacturing Practices) regulations are required. Good verbal and written communication skills are necessary. Must be detail oriented and able to deal with changing priorities.

Working Conditions: Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.

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 complex 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 Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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.

PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.