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Document Coordinator – Columbus Plant

Abbott Molecular Inc.

This is a Full-time position in Columbus, OH posted July 7, 2020.

Location: Columbus, OH

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 103,000 colleagues serve people in more than 160 countries.

 

JOB DESCRIPTION:

Primary Function / Primary Goals / Objectives:

  • Administer document change control of Work Orders, Plant Procedures, Job Aids and other Quality Assurance controlled documents.
  • Assure that quality documents are properly distributed and controlled internally.
  • Ensure that all necessary documents, filed processes, and other critical factors, formulations and documentation for packaging materials and ingredients are in place prior to production.
  • Preserve and maintain an effective system for making authorized changes to individual Work Orders and other documents.
  • Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Bottled Water Regulations, Nutritional Labeling Laws, and Good Manufacturing Practices.

Major Responsibilities:

  • Writing, updating, revising, and printing merged Work Orders and/or procedures on the AS400 system.
  • Prepare and maintain all quality-related documents, manuals, protocols, deviation work order related material, procedures, issuances, and methods that define and document the quality control system.
  • Updating the valid combination files associated with the Master Work Order that includes inputting and formatting the correct data into the Batch Calculation program.
  • Write, update, route, track, issue, and implement all Master Work Orders and Quality related documents in accordance with Division Quality Assurance Documents Policy.
  • Coordinate changes in the labeling and packaging materials with the correct formulations as required by the Master Specifications Manual.
  • Comply with department expectations.
  • Change control of Work Order and other QA documents.  Coordinate document changes with Plant and Division representatives.
  • Arbitrate and resolve differences among various departments to assure that proposed changes follow the Plant, Division, and Corporate guidelines.
  • Perform other specific duties as assigned by the supervisor or manager, especially during the absence of other team members.
  • Review process changes accurately before submitting to Sr. Documents Coordinator, Team Leader, or Supervisor.
  • Identify and resolve conflicts, errors or omissions in change requests, DCA or any other quality documents.

           

Education:

Bachelors’ degree in a technical field preferred.  High school diploma or equivalent required.

Background:

  • Some knowledge of manufacturing processes associated with making a batch is required.
  • Knowledge of the AS400 word processing system is desired.
  • Proficient skills with computer and management information systems.
  • QA related experience (ex. Technician, Batch Log Auditor, or related position) and 1 year as Assistant Document Coordinator preferred.

Accountability / Scope/Budget:

The position will work under the direction of the Quality Systems Supervisor or Manager.  Occasionally the person will receive direction from Division Quality Assurance.  The position is independent.  The Document Coordinators are expected to review their work for errors and correct before submitting for Sr. Documents Coordinator or Supervisor for review.  Errors could result in an FDA observation, Corporate Compliance Audit Observation, Recall, OSHA, or other regulatory action.

 

JOB FAMILY:

Operations Quality

 

DIVISION:

ANSC Nutrition Supply Chain

 

LOCATION:

United States > Columbus : Columbus Plant

 

ADDITIONAL LOCATIONS:

 

WORK SHIFT:

Standard

 

TRAVEL:

No

 

MEDICAL SURVEILLANCE:

No

 

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)