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Manager, Production Support

Company: Abbott
Location: Santa Rosa
Posted on: June 12, 2019

Job Description:

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 clients.


* Ensure all laboratory reagents/solutions are prepared in a timely manner and tested for quality/accuracy prior to use in production.

* 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 serum.

* 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 assays.

* 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 documentation.

* 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 staff.

* Evaluate quality control records for all laboratory testing performed.

* 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 inspections.



Through understanding of methodologies used in a forensic toxicology laboratory.

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 parties.

Ability to develop written procedures and perform technical report writing.

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 laboratory setting.


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, on LinkedIn at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.


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

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