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Quality Systems Compliance Manager- Casa Grande, AZ

Employer
Abbott Laboratories
Location
Casa Grande, AZ
Closing date
Jan 25, 2022

View more

Sector
Other
Organization Type
Corporate
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 109,000 colleagues serve people in more than 160 countries.

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.

Our location in Casa Grande, Arizona currently has an opportunity for a Quality Compliance Officer. This site 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 400 that works together to help nourish the world.

What you'll do as a Quality Compliance Officer:

The Plant Quality Compliance Officer is responsible for managing the Plant Compliance Daily Operations at the site. The Plant Quality Compliance Officer is responsible for ensuring policies and procedures are appropriately followed in relation to cGMP's, Quality Systems Elements and the CAPA system. Drives the global corrective actions at a plant level and ensures corrections are followed through to completion. Supports plant initiatives at the site for compliance-related issues.

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; coordinating Management Review activities and elevating potential problems and issues to plant Management.
  • Responsible for reviewing, implementing and maintaining the effectiveness of the quality system.
  • Assures all functional areas of the plant comply with all GMPS, FDA regulations and other practices outlined by federal statutes or other regulatory agencies. 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 one of the plants 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 owns the development and execution of the validation and verification activities for all plant prerequisite programs, control measures and critical limits.
  • Ensure preparation and readiness for site regulatory inspections and all pre and internal and external post inspection activities.

Education and experience you'll bring:

Required: Bachelor's Degree in a Business, Science or Technical are: Engineering or Food Science Preferred.
  • Minimum of 7 years of progressive responsibility in a quality environment with prior internal and external auditing responsibilities preferred.
  • A minimum of seven years of knowledge related to food processing techniques, federal and state regulations and documentation practices. .
  • Knowledgeable with working experience of Quality Systems (HACCP, SQF, GMP). Prior experience working in a manufacturing facility governed by the following food regulatory guidelines (OU, GMP, HACCP, FDA).
  • This position requires good technical writing, excellent communication and analytical skills. Understanding of Low Acid Food regulations, Infant formula regulations, kosher and Halal laws, and other governmental regulations affecting the manufacturing and distribution of Infant formula and nutritionals products.

Position could have up to two direct reports.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • A 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
  • Paid time off
  • 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: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Preferred;
  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals
  • HACCP certification, SQF practitioner certification and PCQI.

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