QA Documents Coordinator — Change Control & Compliance

Abbott Laboratories; Sturgis, Northern (MI, KY); Hybrid; USD 29,000 - 58,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories in Sturgis, MI, within the Nutrition division, seeks a Documents Coordinator to manage QA document changes and ensure proper distribution and control. The role involves coordinating with multiple departments, tracking changes in Work Orders and procedures, and maintaining compliance with regulatory standards.

You will help prepare for audits, print batch orders, and support QA activities, leveraging knowledge of FDA/OSHA rules, AS400, and office software.

Qualifications

• High School Diploma or GED required; technical degree preferred.
• Knowledge of regulatory standards for infant formula/nutritionals.
• Technical knowledge of food manufacturing processes.
• Proficient with computers and management information systems.

Responsibilities

• Administer document change control of work orders, plant procedures, job aids and QA documents.
• Meet with departments to discuss work order updates.
• Distribute and control quality documents internally.
• Preserve and maintain an effective change-tracking system for QA documents.
• Ensure documents for packaging materials and ingredients are in place prior to production.
• Comply with FDA/OSHA and Abbott policies and procedures.
• Route, track and issue deviations, procedures, work orders and shelf life reports.
• Print batch-specific work orders with correct batch numbers.
• Order supplies and assist QS during audits.
• Track data and publish reports for outstanding documents.
• Assist Senior Document Coordinators and take on related responsibilities.

Skills

Effective communication

Regulatory knowledge

Food manufacturing processes

Computer & MIS skills

Education

High School Diploma or GED

Bachelor's Degree in a technical field

Tools

AS400

Word processing systems

Job description

Abbott Laboratories in Sturgis, MI, within the Nutrition division, seeks a Documents Coordinator to manage QA document changes and ensure proper distribution and control. The role involves coordinating with multiple departments, tracking changes in Work Orders and procedures, and maintaining compliance with regulatory standards.

You will help prepare for audits, print batch orders, and support QA activities, leveraging knowledge of FDA/OSHA rules, AS400, and office software.