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Offers “Abbott”

Expires soon Abbott

QA Coordinator

  • Internship
  • DOMINICAN REPUBLIC

Job description

JOB DESCRIPTION:

This position is for Abbott Nutrition Division in commercial offices in Santo Domingo, Dominican Republic.

Primary Job Function

Ensure Abbott quality standards and policies compliance as well as local regulations for the countries were ANI products are marketed, that are distributed from the third-party logistics operator warehouse. Guarantee the correct storage and rework of the products as applicable, according to the Good Manufacturing and Storage Practices.

Core Job Responsibilities

  • Inspection of the areas where ANI product is stored. Assure the areas are clean and organized, that the product is correctly stored, in the stablished location, and identified with a status, as per Good Storage Practices and local regulations.
  • Review the temperature reports for the warehouses where ANI products are stored. Review pest control reports and follow up required actions if applicable.
  • Approve and revise the inspection forms upon product arrival to the warehouse, to assign the locations that are defined and correct. Review and approve the outbound inspection formats, to assure the products dispatch to the different customers comply with quality and rework requirements.
  • Issue and review work instructions for rework processes to be performed at the logistics operator warehouse. Issue/approve product status changes in the Warehouse Management system from Quarantine/QA Hold/Rejected to other locations.
  • Issue and coordinate work orders per Supply Chain area requests and local Overlabeling Matrix issued by Regulatory Affairs. Make cross reference with the original packaging and the local overlabeling packaging per process. Approve the materials and print legends related to rework processes.
  • Manage the work order database. Issue and follow up on product quality and distribution complaints.
  • Approve packaging material incoming or outbound changes in the WMS. Supervise correct packaging material storage, management and flow in the warehouse, incoming/outbound and rework areas. Correct material identification revision. Confirm correct packaging material inventory in the system and replenishment as needed.
  • Audit schedule, execution, issue of reports and follow up on actions until closure.
  • Notify new product packaging or change in packaging upon receipt.
  • Quality Assurance Manager Backup.
  • Other:
  • Review and support adequate product return when applicable
  • Train warehouse personnel related to Abbott products or operations
  • Train personnel in processes and quality systems.
  • Perform periodic inspections to review GWPs compliance.
  • Generate the monthly rework report.
  • Generate discrepancy reports.
  • Verify annual calibration of equipment when applicable.
  • Line clearance, periodic review, and control.
  • Coordinate the destruction of obsolete printed material.

Minimum Education

Required:

  • College degree in Pharmaceutical active status in the Pharmacists Local Association.

Minimum Experience/Training Required

Required:

  • 2 years of experience in similar position

Desirable:

  • 1-year regional experience in Central America and/or Dominican Republic

Other Requirements

Language:

  • Advance level English, written and verbal.

Competencies:

  • Good Warehouse and Manufacturing Practices basic knowledge
  • Local warehouse operation legislation knowledge
  • Attention to detail
  • Ethical
  • Critical Thinking
  • Adaptability
  • Teamwork

Travel: Availability to travel once per trimester or per required activities.

Fieldwork: Availability to visit vendors, destruction facilities, distributors or other quality related stakeholders.

JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

Dominican Republic : Remote

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)