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Quality Systems Manager

Company: Abbott Laboratories
Location: Sacaton
Posted on: September 24, 2022

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 113,000 colleagues serve people in more than 160 countries.About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Abbott's Nutrition Division develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , Glucerna and ZonePerfect - to help get the nutrients they need to live their healthiest life.WORKING AT ABBOTTAt Abbott, you can have a good job that can grow into a great career. We offer:

  • Fast paced work environment where your safety is our priority
  • Production areas that are clean, well-lit and temperature-controlled
  • Training and career development , with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
  • Vacation - 3 weeks accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
  • Company Paid Pension Plan
  • 401(k) retirement savings with a generous company match of 5%
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities
  • Learn more about our benefits that add real value to your life to help you live fully: The Opportunity - Quality Systems ManagerThis position works out of our Casa Grande, AZ location in the Abbott Nutrition Division. Casa Grande, Ariz., is one of six Abbott nutrition manufacturing plants in the U.S., with about half of its products exported around the world. Working here, you'll feel part of a family - a family of 480+ that works together to help nourish the world. What You'll Work On:The Quality Systems Manager has responsibility for managing and improving the ongoing batch auditing and product release system, managing and improving plant quality control systems including document change control and addressing nonconforming materials and other quality issues with DQA, Process Authority, Medical, R&D and other appropriate groups outside the plant environment.Major Responsibilities:Responsible for implementing and maintaining the effectiveness of the quality system. Manages the Documentation System: Manages and improves the QA Work Order system, both electronic and paper systems. Manage and improves document routing system to assure timely implementation of requested change. Assures that all QA documents meet established divisional, corporate and regulatory standards. Reviews document change requests, as needed, in order to identify all documents affected and all appropriate parties review the document prior to implementation. Monitors product formulation changes and issuance to correspond with labeling materials, as needed. Assures that all QA documents are current. Identifies gaps in Plant Documentation and Systems and take necessary actions to correct. Manages the Batch Log System and Nonconformances (products and processes): Audits batch records to assure that the batch files comply with all policies, procedures and regulations affecting the product, as needed. Provides Batch Log trend information to the plant and Division. Develops systems to track, trend, report and reduce nonconforming situations. Identifies all batch nonconformance and initiate appropriate actions for those nonconformances. Assures that continuing nonconformances have follow-up action plans to correct the problem. Assures validation requirements are fulfilled on plant wide changes prior to product release. Controls Release of Product to Market and Quality Hold Program. Issues Finished Product Shipping Releases in a timely manner for all conforming material goods. Coordinates the quarantine of nonconforming finished product. Reports status of materials not meeting normal release times (Hold List or Delayed Release List). Coordinates priority finished product releases with Manufacturing and Logistics. Interfaces with third party manufactures of Abbott Nutrition Products to assure same internal Quality Standards are maintained during the manufacture of product, as required. Provides Liaison to the Division Staff as follows: Coordinates of requests for destruction and rework of materials. Coordinates in-plant execution of the Divisions product surveillance program. Develops and issue quality reports related to problems, routine QA data, and those systems under Quality System's responsibility.Assures financial performance goals are met.Conducts performance reviews; develops growth plans; interprets, implements and supportsemployee-related policies, procedures and programs. Assigns projects/tasks to direct staff.Assures compliance to all procedures and policies concerning all areas of quality, regulatory, safety and human resources for all departments.The Quality Systems Manager assures that all documents and operations in the plant are in compliance with the standards established by Abbott and other regulatory agencies. Job function include final disposition of all manufactured products valued at over 250 million annually. Failure to uphold these standards could result in product recall, loss of market share and consumer endangerment.WHAT YOU'LL BRING:Education:Bachelor' Degree REQUIRED in a Technical, Business or Science field. Master's Degree preferred. Experience:
    • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals
    • 4+ years - knowledge of food processing techniques, laboratory procedures, Low Acid Food Regulations
    • 2+ years - Supervisory/Leadership ExperienceEducation/Experience Apply Now Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.Abbott is an Equal Opportunity Employer, committed to employee diversity and a Military/Veteran Friendly employer. Connect with us at , on Facebook at and on

Keywords: Abbott Laboratories, Phoenix , Quality Systems Manager, Executive , Sacaton, Arizona

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