Documents Coordinator - Sturgis, MI Plant (1st Shift)

Job description

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
• Meeting with multiple departments to discuss work order updates
• Assure quality documents are properly distributed and controlled internally
• Preserve, track and maintain an effective system for making authorized changes to individual Work Orders and other quality documents in Teamcenter
• 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
• Comply with Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Nutritional Labeling Laws and Good Manufacturing Practices

Major Responsibilities:

• Accurately route, track and issue the following Quality Documents:  Deviations, Procedures, Work Orders, Division Documents and Shelf Life Reports
• Print batch specific work orders, ensuring that each work order is accurate in batch number, stock code and version number
• Order supplies
• Assist QS department management during Audits
• Miscellaneous typing and correspondence
• Track data and publish reports for outstanding documents
• Identify and resolve conflicts, errors or omissions in change requests or any other quality documents
• Assist Senior Document Coordinators in varying capacity with projects as needed
• Takes on various Document Coordinator responsibilities

Education:

High School Diploma or equivalent required; Bachelors’ Degree in a technical field preferred.

Background:

• Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals
• Technical knowledge of food manufacturing processes
• Knowledge of the AS400 and word processing systems is desired
• Proficient skills with computer and management information systems
• 1 year with QA related experience preferred

Accountability/Scope/Budget:

• This position is independent but works under the direction of the Quality Systems Front Line Leader or Manager
• Occasionally this person will receive direction from Division Quality Assurance
• Document Coordinators are expected to review their work for errors and correct before submitting for Senior Documents Coordinator or Front Line Leader for review
• Errors could result in an FDA observation, Corporate Compliance Audit Observation, Recall, OSHA or other regulatory action

JOB FAMILY:

DIVISION:

LOCATION:

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MEDICAL SURVEILLANCE:

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