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Abbott

Makes heart devices, glucose sensors and lab tests

Quality Systems Document Coordinator

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeCasa Grande, AZ, USA$19.05 - $38.15 /hr

About the Job

Requirements

  • A high school diploma or GED is required.
  • At least three years of experience in Quality Assurance, Quality Systems, Document Control, Manufacturing, Laboratory Operations, or another regulated environment is required.
  • Working knowledge of manufacturing processes and controlled documentation practices is required.
  • Experience reviewing technical documents with attention to detail and accuracy is required.
  • Strong organizational, prioritization, and time management skills are required.
  • Ability to collaborate across departments and manage competing priorities is required.
  • Eligibility to work in the United States must be verified upon hire.

Responsibilities

  • Manage document change control activities for procedures, work orders, specifications, forms, job aids, and other quality-controlled documents.
  • Create, review, revise, route, and maintain quality system documents within electronic document management systems.
  • Perform batch calculations and verifications to support production schedules.
  • Develop and maintain work order attachments and supporting documentation for manufacturing activities.
  • Support change control and deviation implementation activities, ensuring required documentation updates are completed accurately and on time.
  • Coordinate document reviews and collaborate with cross-functional teams to resolve documentation discrepancies.
  • Support new product introductions, process changes, and continuous improvement initiatives affecting Quality Systems.
  • Ensure formulations, packaging specifications, ingredient records, and production documentation are accurate and available before manufacturing.
  • Generate reports related to document control activities, compliance requirements, and periodic reviews.
  • Participate in cross-functional meetings to support production readiness and quality system compliance.
  • Maintain quality records in accordance with company procedures and regulatory requirements.
  • Provide backup support for Quality Systems activities and perform other duties as assigned.

Desired Qualifications

  • An associate or bachelor’s degree in a scientific, technical, quality, or business-related discipline is preferred.
  • Experience in food, pharmaceutical, medical device, or other regulated manufacturing environments is preferred.
  • Experience using electronic document management systems such as M-Files is preferred.
  • Experience with AS400 and work order management processes is preferred.
  • Knowledge of change control, deviations, CAPA, and Quality Management System processes is preferred.
  • Experience supporting batch calculations, formulation changes, or production documentation is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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