Senior Quality Assurance Auditor (3 Days On-site/ 2 Days Remote)
Company: PRA Health Sciences
Posted on: January 15, 2022
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
With our patients at the center of all that we do, we help to
accelerate the development of drugs and devices that save lives and
improve quality of life.
Our people are our greatest strength, are at the core of our
culture, and the driving force behind our success. ICON people have
a mission to succeed and a passion that ensures what we do, we do
Perform quality and auditing activities to assess compliance with
corporate policies, industry standards, and applicable regulations.
This includes conducting a variety of audit activities which may
include, but not be limited to. internal process audits,
pharmacovigilance audits, study specific audits (e.g. investigator
site, in process, pharmacy/distribution, trial master file),
hosting of sponsor audits and audits of vendors used to support
ICON services. Provide GCP consultation to the ICON
Level 3 auditor independently conducts the following activities as
assigned by Quality & Compliance (Q&C) management:
Performs contracted, routine and complex audits according to client
expectations and/or ICON SOPs. Often assigned to act as Audit Lead
for a team of auditors and/or to conduct complex audits
Plans and ensures audits are scheduled.
Conducts audits to assess adherence to protocols, SOPs,
regulations, GCP, and expectations for data accuracy and
Reports observations/findings according to client or ICON SOPs and
report templates within defined timelines.
Tracks, collects and issues responses and corrective actions
according to client or ICON SOPs.
Documents closure of audit
Interprets regulations and guidance documents governing GCP and
provides the interpretation to ICON staff and clients.
Facilitates client audits and regulatory inspections of ICON.
Participates in Q&C projects such as management of issue
escalations, CAPA projects, or other Q&C initiatives.
Read, write and speak fluent English.
5+ years experience working in a clinical, regulatory,
pharmacovigilance, or quality environment within CRO/
pharmaceutical / healthcare industry.
Excellent verbal and written communication skills and interpersonal
Excellent organizational skills.
Must possess a technical knowledge that is applicable to clinical
An undergraduate degree, its international equivalent in the
sciences, technology, auditing, etc. from an accredited institution
or sufficient previous experience in auditing is required
Extensive experience in investigator site, vendor, and process
Candidate should live near St. Lake City Site to work (3) Days on
Site, Remote (2) Day a Week
To qualify, applicants must be legally authorized to work in the
United States, and should not require, now or in the future,
sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing
opportunities to minorities, women, veterans and individuals with
Keywords: PRA Health Sciences, Garland , Senior Quality Assurance Auditor (3 Days On-site/ 2 Days Remote), Accounting, Auditing , Garland, Texas
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