Quality Assurance Analyst -
USANA is seeking a Quality Assurance Analyst
with working knowledge of
Quality Engineering to be responsible for all activities involving
quality
assurance and compliance with applicable GMP and corporate quality
requirements.
Duties
Responsibilities include writing, reviewing, and revising SOPs as well
as
writing and executing validation protocols (Equipment and Process
Validation
(IQ/OQ/PQ, Cleaning Validation, Test Method Validation). The
QA Analyst will
track, trend, and report QA related information
(Deviations, CAPA,
OOS, Complaints), track and trend environmental
Monitoring
programs
(temperature/humidity, water, air monitoring),and maintain the
Internal Audit
program (track, conduct , and report audits). In
addition
the QA Analyst will administer, review, follow-up, and approve
CAPA’s
(Corrective and
Preventive Action), maintain the product
Stability
Program
(collect/track samples, review data, final reports), maintain
the
Approved Suppliers List and prepare vendor/supplier GMP Agreements.
The QA Analyst will
also lead or assist in Investigations related to
complaints
and manufactured products, prepare routine status reports of
Quality Assurance activities, and assist with preparation for regulato!
ry inspections.
Qualifications
Candidates must have a bachelor's degree in a scientific
field of
study,
five or more years of experience in a quality assurance role in a
pharmaceutical,
medical device, or dietary supplement environment.
Candidates must have
a working knowledge of cGMP or other quality programs
related
to pharmaceutical, medical device, or dietary supplement
environment
and one or more years of experience as a quality auditor,
investigator,
or quality
engineer. Proficiency in MS Suite and
excellent
communication
skills is required. A background in statistical analysis is
preferred
and vendor audits are strong plus.
Contact: USANA Health Sciences
3838 W
Parkway Blvd.
E-mail: hrusana@usana.com
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