QA Auditor III

Responsibilities:Performs technical document review and other GxP practice activities in support of clinical development programs.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.

Prepares and provides audit reports to management.Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and data audits for clients and projects.

Responsibilities:Performs technical document review and other GxP practice activities in support of clinical development programs.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.

Prepares and provides audit reports to management.Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and data audits for clients and projects.

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification.Preferably individual with strong background and knowledge in the following: Biochemistry, Immunochemistry and/or Vaccinology, from either CRO and/ or pharmaceutical industry.Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience.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 skills (Effectively bilingual in English and Mandarin)Highly meticulous with a keen eye for detailStrong problem solving, risk assessment and impact analysis abilitiesFlexible and able to multi-task and prioritize competing demands/work loadSolid experience in root cause analysisAbove average negotiation and conflict management skillsValid driver's licenseWorking 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 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.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.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification.Preferably individual with strong background and knowledge in the following: Biochemistry, Immunochemistry and/or Vaccinology, from either CRO and/ or pharmaceutical industry.Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience.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 skills (Effectively bilingual in English and Mandarin)Highly meticulous with a keen eye for detailStrong problem solving, risk assessment and impact analysis abilitiesFlexible and able to multi-task and prioritize competing demands/work loadSolid experience in root cause analysisAbove average negotiation and conflict management skillsValid driver's licenseWorking 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 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.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.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.