Quality Specialist
Company: bioMerieux Inc.
Location: Salt Lake City
Posted on: October 8, 2024
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Job Description:
Quality Specialist
Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
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A world leader in the field of in vitro diagnostics for more than
60 years, bioMerieux provides diagnostic solutions which determine
the source of disease and contamination to improve patient health
and ensure consumer safety.In North America we have more than 6,200
team members across 11 sites or subsidiaries, including Salt Lake
City-based BioFire Diagnostics and one subsidiary in Montreal,
Canada.Come and join a family-owned global company with a long-term
vision, and a human-centered culture.
Description
This is a full-time, hourly position that provides support through
inspection of raw materials. As a Quality representative, the
employee will assess and monitor both process and product. Timely
and accurate work as well as a high level of self-direction and
motivation is expected. Regular cross functional interaction and
collaboration with attention to detail is required. Work is fast
paced and requires prioritization of daily tasks. Effective
communication, written and verbal, is critical. DescriptionPerform
all work in compliance with company policy and within the
guidelines of its Quality System.Responsible for reviewing,
assessing and monitoring process and product to ensure compliance
to requirements.May contribute to other Quality Assurance subunits
that are outside of their primary Quality Assurance subunit, as
assigned.Work on quality improvement projects, (e.g. projects
stemming from CAPAs, training deficiencies, and general procedural
improvements)May present project related information to management
as requested.Perform inspection of incoming materials using basic
and advanced measurement toolsPerform quarantine activities
including physical and electronic segregation, labeling, physical
and electronic releaseInitiate NCRs with a thorough description of
the nonconformance including target as well as discrepancy,
quantity and standard used for rejectionComplete first article
inspections.Perform and manage sorting activities to
completionIdentify need for WID updates and initiate WID
updatesSupport and/or manage validation testing, e.g. GR&R and
program validation activities.Initiate and author IC documents
(Inspection plan)Support/interact with Materials Management,
Engineers, Purchasing, and suppliers. This includes research
activities and special projects.Perform sweeps of warehouse area to
ensure cGMP compliance with a lead auditorReview co-worker
completed inspection recordsMentor techniciansInitiate routines and
programs for metrology tools under engineer guidanceCoordinate
activities for metrology tool calibrationEnsure compliance to
Temporary Change Orders; manage expiration status Interpret and
utilize SPC chart data Analyze trends and participate in metrics
development Participate as a subject matter expert in internal and
external audits of the Incoming Inspection team. Write validation
protocols Input data into MiniTab and work with Engineering on
analysis of validation data Training and Education High school
diploma or equivalent is requiredAssociate degree (or higher) in a
life science or engineering discipline is preferred.Knowledge of
good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR
820 is requiredEnrollment in the Salt Lake Community College
Medical Device Manufacturing Program or equivalent (e.g. ASQ
certification; Six Sigma certification; life science or engineering
related college degree) is preferred. Experience Minimum 1-year
previous on-the-job experience requiring professional communication
and interactions utilizing skills outlined below.Minimum additional
2-year experience in a Quality Assurance, Quality Control,
laboratory or life science or other manufacturing setting that has
a formal quality system. Education/certification in Quality
Management Systems may be used in lieu of 1-year of this
experience5 years combined above experience is preferred Skills &
Qualifications:Preferred specialized expertise such as IPC610
and/or IPC620 certified, GD&T background, problem solving,
technical writing, black belt.Effective written and verbal
communication skillsProficiency in MS Office tools, including
Outlook, Word, and ExcelGeneral computer operationAttention to
detail is fundamental to this position.Ability to accurately follow
written and verbal instructions.Organization skills as needed to
maintain paperwork and task schedule.Proficiency in internet
navigationBasic math proficiencyAbility to write standardized and
clear instructions Demonstrated skill set and knowledge of
inspection methodologies and techniques assessed through competency
testing during the interview process. Physical Requirements:Must be
willing to submit to a color-vision test, though result of the test
will not determine employment eligibilityMust be able to push,
pull, bend, and/or lift at least 25 lbs, and may be required to
lift up to 50 lbs., for extended periods of time on a daily
basis.
Please be aware that recruitment related scams are on the rise.
Fraudulent job postings are being placed on other websites, and
individuals posing as bioMerieux Talent Acquisition team members
are reaching out via email or text message in an attempt to collect
your personal and confidential information. In some cases, these
scammers are also conducting bogus interviews prior to extending
fraudulent offers of employment. Beware of individuals reaching out
using general phone numbers and non-bioMerieux email domains (i.e.
Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that
an interview experience or offer of employment might be a scam,
please make sure you are searching for the posting on our careers
site or contact us at .
BioMerieux Inc. and its affiliates are Equal
Opportunity/Affirmative Action Employers. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, age, protected veteran or disabled status, or genetic
information. Please be advised that the receipt of satisfactory
responses to reference requests and the provision of satisfactory
proof of an applicant's identity and legal authorization to work in
the United States are required of all new hires. Any
misrepresentation, falsification, or material omission may result
in the failure to receive an offer, the retraction of an offer, or
if already hired, dismissal. If you are a qualified individual with
a disability, you may request a reasonable accommodation in
BioMerieux's or its affiliates' application process by contacting
us via telephone at (385) 770-1132, by email at
recruitment@biomerieux.com, or by dialing 711 for access to
Telecommunications Relay Services (TRS).
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Keywords: bioMerieux Inc., Logan , Quality Specialist, Other , Salt Lake City, Utah
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