Manager, Production Support
Location: Santa Rosa
Posted on: June 12, 2019
Abbott Rapid Diagnostics is part of Abbotts 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 Quality Manager is within our Toxicology
Laboratories located at Santa Rosa, CA. The QC Manager will be
responsible for the planning, coordination and control of
reagent/solution preparation for all working reagents, calibrators
and controls used in various areas of the laboratory. Additionally,
Communication with the direct supervisor and other lab management
is essential for smooth operations of the confirmation laboratory.
Process control is the key responsibility of the QC manager. This
role will instrumental in providing quality results to our
* Ensure all laboratory reagents/solutions are prepared in a timely
manner and tested for quality/accuracy prior to use in
* Ensure timely completion of all internal and external proficiency
testing. Send out, track and review all In-house, external,
internal and blind proficiency testing in oral fluid, urine and
* Monitor inventory of reference standards and bulk reagents and
place orders for drug standards, pricing of standards.
* Maintain inventory of working reagents and standards and ensure
adequacy to support production lab.
* Assist staff with troubleshooting the failed QC runs, tracking
and organization of solutions when necessary.
* Recommend changes to preparation and storage sections of SOP,
when necessary, to accommodate increased volumes.
* Recommend changes to work flow processes in all areas of the
laboratory to improve efficiency and quality.
* Manage the specimen retention program for the laboratory.
* Perform annual uncertainty calculations for all quantitative
* Perform monthly review of QC data (Levey Jennings Charts) and
facilitate sign-offs by appropriate authority.
* Check, review, and educate all laboratory personnel regarding
daily, weekly, and monthly quality control procedures as well as
* Review laboratory calibrations, QC and donor results routinely to
identify any opportunities for improvement.
* Pulling pending logs to ensure orders are not missed.
* Ensure that remedial actions are taken and documented whenever
significant deviations from the laboratorys established performance
characteristics are identified, and that patient test results are
reported only when the system is functioning properly.
* Ensure that appropriate technical staff review QC regularly to
confirm that policies and procedures are being followed by all
* Evaluate quality control records for all laboratory testing
* Ensures the Quality System is maintained in compliance with all
applicable Quality System Regulations.
* Ensures test quality meets excellence goals.
* Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system.
* Review proficiency testing records to ensure that all testing is
performed according to CLIA specifications and asses the corrective
action to help ensure that test accuracy is maintained.
* Assist in all aspects regarding all laboratory regulatory
Through understanding of methodologies used in a forensic
Understanding of the LCMS systems and data analysis.
Ability to communicate effectively to a variety of audiences
Solid working experience in a position related to Quality
Management Systems including good understanding of requirements for
documentation and training management.
Demonstrated ability to work effectively with cross functional
groups and build strong relationships with internal and/or external
Ability to develop written procedures and perform technical report
Knowledge of Lean and Six Sigma principles and experience using
those tools in improvement activities preferred.
Strong data analysis, data management, and quantitative skills.
* Bachelors Degree in chemical, physical or biological science from
an accredited educational institution.
* At least 2 years training/experience in a high complexity lab,
and 2 years supervisory experience.
Prior track record of success managing a Quality System in a
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 103,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
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
Keywords: Abbott, Santa Rosa , Manager, Production Support, Professions , Santa Rosa, California
Didn't find what you're looking for? Search again!