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Manager Compliance and Micro Lab - Fairfield CA Plant

Company: Abbott Laboratories
Location: Fairfield
Posted on: August 1, 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.Nourish the world and your career as part of the Nutrition team at Abbott.Our Nutrition business 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. WHAT WE OFFER:At Abbott, you can have a good job that can grow into a great career. We offer:

  • 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 (1st yr prorated) + vacation buy program + 3 personal days + 10 paid holidays
  • Company Paid Pension Plan
  • 401(k) retirement savings with a generous company match
  • 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: - WHAT YOU'LL DO:The Plant Quality Compliance Manager is responsible for managing Plant Compliance Operations and Plant Quality Engineers. The Plant Quality Compliance/Services Manager is responsible for ensuring methods and procedures are appropriately followed; ensuring CAPA activities associated with global corrective actions and product improvement are followed through to completion; providing direction and leadership to plant staff and QEs for compliance-related issues and for key projects and business initiatives. The Plant Compliance functions include: managing all plant areas to comply with GMPs, FDA regulations and other practices outlined by federal statutes or other regulatory agencies; managing all FDA, Rabbinical, Halal, Third Party, Corporate and Division audits; managing and executing the internal audit program; serving as the Plant Safe Quality Food (SQF) Practitioner and Food Safety Plan coordinator; providing continuous improvement support to key Business Excellence projects; coordinating Management Review activities and elevating potential problems and issues to plant and Division Management. The position is required to monitor our industry and FDA trends that affect continuous improvement and ever improving cGMP's. The Quality Engineering functions include: reviewing RCEs to assure GMP and potential product hazards contribute to development of appropriate process designs and validation protocols; assisting in execution of validation protocols, supporting initial start-up production after engineering changes and/ or after producing new products and performing product assurance reviews and identifying key quality issues and assuring their resolution. (FF Compliance MGR doesn't manage QEs). Compliance responsibilities: Assures all functional areas of the plant comply with all GMPS, FDA regulations and other practices outlined by federal statutes or other regulatory agencies. Serves as the key plant contact for all FDA, Rabbinical, Third party, Corporate and Division audits. Assures that the plant is well-prepared for the audit and manages all activities during the audit. Manages and executes the internal audit program. Works with plant personnel to develop and implement appropriate action plans for all audit observations. Assures that the corrective action plans are applied globally and consistently throughout the plant. Serves as the plant Safe Quality Food (SQF) Practitioner. The SQF Practitioner reviews and approves all plant document changes and validation changes for impact on the SQF system. The SQF Practitioner is responsible for developing and maintaining the plant Food Safety Plan program. The SQF Practitioner develops and executes the validation and verification activities for all plant prerequisite programs, control measures and critical limits. Provides continuous process improvement support for all key projects using the Business Excellence tools and techniques. Assures the projects and systems are lean and effective to maximize productivity. Reviews all complaint investigations and implements corrective actions, when necessary. QE responsibilities: Provides Quality Assurance design review support to plant projects initiated by R.C.E. or other means. Coordinates the introduction to the plant of new products, processes, and packages. Assures that the plant validation program is executed consistently with the Abbott Nutrition Validation Policies. Develops Master Work Orders, plant procedures and deviation procedures as necessary in support of plant projects, new processes, and new packages. Implements productivity improvement projects, analyzes plant quality costs and material variances relevant to Quality Assurance. Implements SPC process and procedures throughout plant. Additional responsibilities: Coaches, develops, and mentors' employees in areas of responsibility. Responsible for recruitment, selection, development and retention of employees. Conducts performance reviews; develops growth plans; interprets, implements and supports employee-related policies, procedures and programs. Assigns projects/tasks to direct staff. Interfaces with Division and Corporate QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of project activities. Provides technical guidance and support to plant. EDUCATION AND EXPERIENCE YOU'LL BRING:Bachelor's Degree in a Business, Science or Technical area Preferred or equivalent work experience; Engineering or Food Science Preferred. 4 years knowledge of food processing techniques, federal and state regulations, documentation requirements and statistical applications is essential. Two years supervisory/leadership required. This position must have good technical background and a thorough understanding of Low Acid Food regulations, Infant formula regulations, kosher and Halal laws, Corporate and Division policies, plant procedures and other governmental regulations affecting the manufacturing and distribution of product produced at the plant. The Plant QA Compliance Manager must be both aggressive and creative in solving problems to avoid significant production downtime and/or product losses or recalls. Needs to be able to identify many alternative solutions to quality issues related to new/revised designs. Ability to apply appropriate statistical methods to better under and improve plant equipment and processes, evaluate new or changed equipment or processes and resolve quality problems. This position is accountable for maintaining and complying with FDA, USDA, OSHA and Affirmative Action requirements. Noncompliance or failure to meet the above could result in department losses which have direct effect on our ability to meet customer expectations, thus having significant impact on Abbott Nutrition business. Responsible for ensuring proper equipment/manpower utilization, good employee relations, a safe environment, quality products and profitability; ensuring all regulatory procedures are complied with and no major observations/violations are given.

Keywords: Abbott Laboratories, Fairfield , Manager Compliance and Micro Lab - Fairfield CA Plant, Professions , Fairfield, California

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