GMP QA AUDITOR II

**Full-time benefits including: health, vision and dental insurance, 17 days of PTO (increases with years of service), 11 paid holidays, an annual bonus and annual increase, 401-K company match, competitive pay, and more!

**Flexible work eonvironment

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. Successful completion of PPD Foundation Training.

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 QA Auditor I plus:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines

• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management

• Excellent oral and written communication skills

• Strong problem solving, risk assessment and impact analysis abilities

• Solid experience in root cause analysis

• Above average negotiation and conflict management skills

• Flexible and able to multi-task and prioritize competing demands/work load

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Environment:

PPD values the health and well-being 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 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 proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.