Documents Coordinator - Sturgis, MI Plant
Core
Administer document change control, track quality documents, and ensure compliance with FDA regulations for infant formula and nutritional products.
Role type
Operations Quality Documents Coordinator
Builds
Quality Assurance controlled documents (Work Orders, Plant Procedures, Job Aids) for Abbott Nutrition production
Domain
Food manufacturing / Infant formula and nutritionals
Required skills
Regulatory standards knowledge (FDA, OSHA, GMP), Food manufacturing process knowledge, Document control systems (M-Files), Data tracking and reporting, Conflict resolution in change requests
Preferred skills
QA related experience, AS400 system knowledge, Bachelor's degree in technical field
Technologies
M-Files, AS400, Word processing systems
Responsibilities
Administer document change control of Work Orders and Plant Procedures; Track and issue Quality Documents (Deviations, Procedures, Shelf Life Reports); Ensure documents are in place prior to production; Comply with Federal Regulations for Infant Formula and Nutritionals; Assist QS management during Audits; Print batch specific work orders accurately
Seniority
Entry-level to Junior, hands-on IC