QA Auditor II
Posted on: June 25, 2022
PPD clinical research services, Thermo Fisher's clinical
research business, is a leading global contract research
organization providing comprehensive, integrated drug development,
laboratory and life cycle management services. At PPD clinical
research services, 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 clinical research services, 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 clinical research services 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.
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.
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
Provides GxP consultation and support to PPD project teams and
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,
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
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic /
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.
Knowledge, Skills and Abilities:
Experienced in handling deviation management and implementing
Thorough knowledge of GxP (GCLP, GCP) and appropriate regional
research regulations and guidelines
Experience with quality management systems such as Trackwise or
Demonstrated proficiency and led a range of project based or
internal GxP audits and vendor audits to high standards required by
Excellent oral and written communication skills
Strong problem solving, risk assessment and impact analysis
Solid experience in root cause analysis
Above average negotiation and conflict management skills
Flexible and able to multi-task and prioritize competing
PPD clinical research services 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
ideaswith diverse groups of peoplein a comprehensible and
Ableto work upright and stationary and/or standingfor typical
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 technologywith
May have exposure to potentially hazardous elements, including
infectious agents, typically found in healthcare or laboratory
Able to perform successfully under pressure while prioritizing and
handling multiple projects or activities.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to
accelerate the delivery of safe and effective therapeutics for some
of the world's most urgent health needs, 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
Keywords: PPD, Richmond , QA Auditor II, Accounting, Auditing , Richmond, Virginia
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