Quality Associate II (QAO & QE LVP Irrigation WMS)
Company: B. Braun Medical Inc
Location: Irvine
Posted on: October 24, 2024
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Job Description:
B. Braun Medical, Inc.B. Braun Medical, Inc.Quality Associate II
(QAO & QE LVP Irrigation WMS)US-CA-IrvineJob ID: 2024-24650Type:
Regular Full-Time# of Openings: 1Category: QualityIrvine
FacilityOverviewAbout B. Braun B. Braun Medical Inc., a leader in
infusion therapy and pain management, develops, manufactures, and
markets innovative medical products and services to the healthcare
industry. Other key product areas include nutrition, pharmacy
admixture and compounding, ostomy and wound care, and dialysis. The
company is committed to eliminating preventable treatment errors
and enhancing patient, clinician and environmental safety. B. Braun
Medical is headquartered in Bethlehem, Pa., and is part of the B.
Braun Group of Companies in the U.S., which includes B. Braun
Interventional Systems, Aesculap-- and CAPS--. Globally, the B.
Braun Group of Companies employs more than 64,000 employees in 64
countries. Guided by its Sharing Expertise-- philosophy, B. Braun
continuously exchanges knowledge with customers, partners and
clinicians to address the critical issues of improving care and
lowering costs. To learn more about B. Braun Medical, visit
www.BBraunUSA.com.ResponsibilitiesPosition Summary: In this vital
role you will support the B. Braun's Injectable Drug Product
Quality Assurance team under the Plant QA organization providing
daily oversight of the LVP Irrigation and WMS manufacturing areas.
Under general supervision by team lead, the role provides support
and compliance oversight to Manufacturing, Reinspection and
Engineering staff in the execution of their processes, procedures,
and use of quality tools. The team provides floor support primarily
for resolution of finished product manufacture and process quality
related issues.This position is also to support Reserve Samples
program, samples staging, replacements and visual inspections, as
well as monitoring of rework/reinspection activities, including
visual and AQL inspections. After the training period this role
will support Quality Mentorship program, Process Verifications
program, Annual Reserve Samples Inspections program.
Responsibilities: Essential DutiesMonitors manufacturing process
verifications to ensure compliance with operating procedures and
specifications. -Provides support for quality investigation which
includes initiation and supporting data for the resolution of
quality issues.Provides Quality oversight over the Quality System,
including but not limited to the review, reports, data (including
Meta data) and records generated to support the manufacturing and
distribution of product.Conducts timely Quality review of
associated data, including data utilized to support batch release,
to meet business and operations requirements.Assists in complying
with regulatory requirements related to product safety and
quality.Ensures that procedures are being followed as outlined
under FDA, ICH, Standard methods and the Quality System
requirements.Reviews records to ensure data meets the industry
requirements for data integrity.The job function listed is not
exhaustive and shall also include any responsibilities as assigned
by the Supervisor from time to time.General: It shall be the duty
of every employee while at work to take reasonable care for safety
and health of himself/herself and other persons." Expertise:
Knowledge & Skills Please refer to the Corporate Guidelines or
BBMUS Guidelines or job specific authorities where applicable. This
list is however not exhaustive and may be amended by the Management
from time to time.Assignments are routine and repetitious in
nature. Work performed within narrowly defined parameters. Follows
established procedures and guidelines.Works under direct
supervision and from detailed verbal and/or written instructions.
Uses established procedures to accomplish assigned task.May require
some limited judgement in resolving problems.Contacts are primarily
with direct supervisor, peers and subordinates.Ability to work
non-standard schedule as needed The targeted range for this role
takes into account a range of factors that are considered when
making compensation and hiring decisions; included but not limited
to: skill sets; experience and training; licensure and
certifications; and other business and organizational needs. The
disclosed range estimate has not been adjusted for the applicable
geographic differential associated with the location at which the
position may be filled. Compensation decisions are dependent on the
facts and circumstances of each case. The range provided is a
reasonable estimate. #ID#LI#ALTarget Based Range $50,367 - $60,440
QualificationsExpertise: Qualifications
-Education/Experience/Training/Etc Required:High school
diploma/G.E.D or equivalent required, Associate's or technical
degree preferred.01-02 years related experience required.Regular
and predictable on-site attendance While performing the duties of
this job, the employee is regularly required to sit and talk or
hear. The employee frequently is required to use hands to handle or
feel and reach with hands and arms. The employee is occasionally
required to stand and walk. The employee must occasionally lift
and/or move up to 20 pounds. . Additional Information
Responsibilities: Other Duties: The preceding functions have been
provided as examples of the types of work performed by employees
assigned to this position. To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed in this description are
representative of the knowledge, skill, and/or ability required.
Management reserves the right to add, modify, change or rescind the
work assignments of different positions due to reasonable
accommodation or other reasons. Physical Demands:While performing
the duties of this job, the employee is expected to:Moderate work -
Exerting up to 20 lbs of force occasionally, and/or up to 10 lbs of
force frequently, and/or 10 lbs force constantly to move
objects.Lifting, Carrying, Pushing, Pulling and
Reaching:Occasionally:Reaching upward and downward,
Push/pullFrequently:Stand, Sit, Visual Acuity with or without
corrective lensesConstantly:N/AActivities:Occasionally:Handling,
Push/pull, Reaching upward and downwardFrequently:Seeing - depth
perception, color vision, field of vision/peripheral, Sitting,
Standing, Talking - ordinary, loud/quick,
WalkingConstantly:N/AEnvironmental
Conditions:Occasionally:N/AFrequently:Proximity to moving
partsConstantly:N/A Work Environment: The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.Noise Intensity:ModerateOccasionally:N/AFrequently:Office
environment, Production/manufacturing environment, Lab
environmentConstantly:N/A What We OfferB. Braun offers an excellent
benefits package, which includes healthcare, a 401(k) plan, and
tuition reimbursement. To learn more about B. Braun and our safety
healthcare products or view a listing of our employment
opportunities, please visit us on the internet at
www.bbraunusa.com.
Through its Sharing Expertise -- initiative, B. Braun promotes best
practices for continuous improvement of healthcare products and
services.NoticesEqual Opportunity Employer Veterans/DisabledAll
qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.Compensation details: 60440 Yearly
SalaryPIae359e374403-25660-35750339
Keywords: B. Braun Medical Inc, Irvine , Quality Associate II (QAO & QE LVP Irrigation WMS), Other , Irvine, California
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