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QA Auditor I - Labs

Title: QA Auditor I - Labs

Department: Quality Assurance, supporting Vaccine Sciences

Location: Richmond, Virginia

*Immediate opening, full benefits*

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 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


Job Qualification:

Education and Experience:
  • Bachelor's degree (biology or forensic science major preferred) and 1-2 years' previous quality assurance, laboratory, or statistical experience required.

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.
  • 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
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Proven flexibility and adaptability
  • 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.

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:
  • 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.
  • Regular and consistent attendance.

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.

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.

Diversity Statement

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.

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