QA Specialist - Reagent Training
Company: bioMerieux
Location: Salt Lake City
Posted on: April 17, 2024
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Job Description:
This is a full-time, non-exempt (hourly) position on the Reagent
Quality Assurance (QA) team with an emphasis in the Reagent
Training sub-unit. This individual will primarily support
task-based training to Reagent Quality Operations members. This
position requires a high level of self-direction and motivation.
Timely, accurate work is expected. The work is fast-paced, and
requires prioritization of daily tasks and attention to detail.
Effective communication, written and verbal, is critical. This
position regularly interacts and collaborates with other
departments within bioMerieux. 4x10 Schedule (Wed-Sat, 1 PM - 11:30
PM) -Principal Job Duties and Responsibilities:Proficiently:Inspect
product (including labels) to specifications and established
procedures. Determine product acceptance status after
inspection.Identify and escalate non-conformances observed during
inspection. Work with production teams to resolve non-conformances
where possible.Ensure good documentation practices during quality
document and quality record review. Report inconsistent or
incorrect records to appropriate systems. - Work with production
teams to resolve erroneous records.Physically release work in
process for finished goods processing.File and archive quality
records according to established processes.Prioritize product
release to meet department goals.Identify and report floor failures
observed during sweeps of manufacturing areas.Review and approve
Device History Records.Receive and hold finished goods inventory
until release is authorized.Release finished goods to stock
inventory.Coordinate molded part validation inventory.Confirm
manufacturing equipment meets requirements for release to
Manufacturing Engineering for validation.Confirm manufacturing
equipment meets specifications for release to Reagent Manufacturing
for use.Control (physically and electronically) material suspected
to be non-conforming.Review Non-conforming Product Reports (NCRs)
for content, accuracy, and clarity.Review and decide if rework
documentation meets requirements for approval and
performance.Physically and electronically disposition NCR-related
materials. Effectively train and mentor QA personnel on Sr. QA
Technician duties and responsibilities.Plan and coordinate timing
of training with respective leaders and other trainers.Prioritize
training to meet training goals.Provide training of Quality
Assurance procedures to Sr. Quality Technicians.Train or assist
with training new hires on required WID's and retrain existing
employees as needed per WID and SOP.Determine if personnel training
that has been administered is sufficient to ensure consistent
execution.Determine trainees' ability to retain knowledge and
skills provided throughout a training.Communicate progress of
assigned trainings to leaders and other trainers.Ensure
documentation of the job training is completed for each skill as
defined.Collaborate with other trainers to ensure quality and
consistency of provided training. Process improvement:Draft new
procedures and revise existing procedures.Collaborate with other
teams/departments as necessary to determine appropriate
instructions for Quality process.Ensure the inputs and outputs of
Quality processes are appropriate for processes of other
teams/departments.Conduct group training sessions for QA personnel
on new and revised procedures.Design, develop, and implement
training curricula.Education & Experience Requirements: High school
diploma (or equivalent) is required.Associate degree (or higher) in
a life science or engineering discipline is preferred.Knowledge of
good manufacturing practices (e.g., ISO 9001, ISO 13485, and/or 21
CFR 820) is required.Enrollment in the Salt Lake Community College
Medical Device Manufacturing Program or equivalent (e.g., ASQ
certification, Six Sigma certification).Minimum 1-year on-the-job
experience requiring professional communication and interactions
utilizing skills addressed outlined herein.Minimum additional
2-year-experience in a Quality Assurance, Quality Control,
laboratory/life science or other manufacturing setting with a
formal quality system (education in Quality Management Systems may
be used in lieu of experience).Skills & Qualifications:Effective
communication skills (written and verbal).Proficiency in MS Office
tools (e.g.Outlook, Word, and Excel) and basic computer
navigation.Ability to accurately follow written and verbal
instructions, as attention to detail is fundamental to this
position.Basic math proficiency.Ability to effectively train,
mentor, and coach other team members.Ability to collaborate with
other team members in order to improve processes and
procedures.Ability to navigate cross functional discussions, lead
meetings, and propose solutions to existing challenges. Physical
Requirements:Must be willing to submit to a color-vision test,
though result of the test will not determine employment
eligibility.Must be able to perform duties wearing a Powered Air
Purifying Respirator (PAPR) as needed.Must be able to perform
duties in a clean room environment. This requires the use of work
attire provided and laundered by the company.Must 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.#BioJobsPandoLogic. Keywords: Quality Control / Quality
Assurance Specialist, Location: SALT LAKE CITY, UT - 84105
Keywords: bioMerieux, Taylorsville , QA Specialist - Reagent Training, Other , Salt Lake City, Utah
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