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Abbott

Makes heart devices, glucose sensors and lab tests

Document Management System Specialist

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeLima, PeruNo salary listed

About the Job

Requirements

  • A completed qualification in Pharmaceutical Chemistry, Engineering, Biology, or a related career is required.
  • At least one year of experience in Quality Assurance, Quality Management, Production, Quality Control, or a similar position is required.

Responsibilities

  • Ensure compliance with the Document Control procedure for the Management System.
  • Ensure compliance with the Quality Records Control procedure.
  • Ensure compliance with the Data Integrity procedure.
  • Ensure the proper internal handling, preservation, archiving, and confidentiality of documentation.
  • Maintain indicators measuring the effectiveness of work related to DARIUS Document System Management.
  • Conduct training on the DARIUS system and associated Good Documentation Practices, and manage system access.
  • Conduct specific inductions in Good Manufacturing Practices.
  • Participate as an Internal Auditor.
  • Control the area budget according to estimates.
  • Support management and carry out other activities or projects assigned by the Quality Management leadership.
  • Manage the ISOSYSTEM document-management software for consultation purposes.
  • Ensure compliance with the document Periodic Review metric.
  • Follow up on IRFs for Corporate Policies.
  • Manage logbooks.
  • Ensure compliance with the Technical Manufacturing Documents Management procedure and coordinate with the Quality Management team to support compliance.
  • Support the review of Bills of Materials in the SAP system.

Desired Qualifications

  • Availability to work at the plant at the Lince site is desirable.

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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