Supervisor, Quality Assurance
Company: Abbott Laboratories
Location: Pomona
Posted on: January 12, 2021
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Job Description:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 107,000 colleagues
serve people in more than 160 countriesAbbott Rapid Diagnostics is
part of Abbott's Diagnostics family of businesses, bringing
together exceptional teams of experts and industry leading
technologies to support diagnostic testing which provides important
information for treatment and management of diseases and other
conditions.The position of Supervisor, Quality Assurance is within
our Toxicology business unit located in Pomona, CA. This role is
responsible for supervising specific quality systems.This job
description will be reviewed periodically and is subject to change
by management.RESPONSIBILITIES:- Manage specific quality systems,
i.e., Incoming Inspection, in-process and Final Product Release,
etc.- Supervises and oversees the activities of the batch record
reviewers and the incoming inspectors- Provides input and
recommendations on incoming inspection forms and procedures-
Reviews and approves change orders- Develops and reports batch
record review performance indicator metrics to management team-
Provides secondary support for other quality subsystems- Maintains
quality system records through the establishment, maintenance of a
centralized documentation archiving system- Manages physical
quality system records for cataloging, archival, retrieval and
scheduled destruction of records in accordance with established
procedures- Reviews and maintains documents used in GMP- Provides
support during regulatory inspection activities- Manages
performance of staff towards department and Company goals,
including feedback on performance, appraisals, recommendations for
merit increases or necessary disciplinary actions, communication to
employees on performance, etc.- Carries out duties in compliance
with established business policies- Demonstrates commitment to the
development, implementation and effectiveness of Alere Quality
Management System per ISO, FDA, and other regulatory agencies-
Responsible for exhibiting professional behavior with both
internal/external business associates that reflects positively on
the company and is consistent with the company's policies and
practices- Understands and is aware of the quality consequences
which may occur from the improper performance of their specific
job. Has awareness of device defects that may occur in their area
of responsibility, including product design, verification and
validation, manufacturing and testing activities.MINIMUM
QUALIFICATIONS - EDUCATION/EXPERIENCE:- Bachelor's Degree in
related discipline or equivalent experience- At least 3 or more
years of experience with at least 1 year of progressively
responsible positions in Quality Assurance- At least 3 or more
years of experience in a lead or supervisory position- Working
knowledge of Quality Assurance in a medical device manufacturing
environment, preferably in-vitro diagnostics--PREFERRED
QUALIFICATIONS:- Excellent written and verbal communication skills-
Expert in using computers, specifically MS Office (MS Word/Excel)-
Able to understand and adhere to quality documentation- Position
requires ability to jointly develop, implement, evaluate, and/or
modify on going "best practices" to assure overall operational
effectiveness- Knowledge of the QSR or ISO 13485 is a plus-
Excellent organization skills - must be able to manage many
simultaneous projects- Attention to detail - must have precision in
their work, especially as it relates to understanding and
documenting complex quality issues--COMPETENCIES:- Leadership-
Initiative- Drives for results- High level of attention to detail-
Collaboration--About Abbott:--At Abbott, we're committed to helping
people live their best possible life through the power of health.
For more than 130 years, we've brought new products and
technologies to the world -- in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals -- that create more
possibilities for more people at all stages of life. Today, 107,000
of us are working to help people live not just longer, but better,
in the more than 160 countries we serve.--An equal opportunity
employer, Abbott welcomes and encourages diversity in our
workforce.--We provide reasonable accommodation to qualified
individuals with disabilities. To request an accommodation, please
send an email to myrecruiter@alere.com.
Keywords: Abbott Laboratories, Pomona , Supervisor, Quality Assurance, Other , Pomona, California
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