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MGS Mfg. Group · 11 hours ago

Document Control Specialist

Richfield, WI

Full-time

Onsite

Entry, Mid Level

2+ years exp

MGS Mfg. Group is a global provider of healthcare manufacturing solutions, and they are seeking a Document Control Specialist at their Richfield, WI facility. The role involves managing company documents, ensuring their accuracy and adherence to quality standards, and preparing Certificates of Analysis for customers.

Industrial EngineeringManufacturing

Responsibilities

Know and follow all of the Company's safety rules, such as safe work practices and standard operating procedures

Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others

Learn and master all necessary areas of the quality system

Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

Review production batch records in accordance with Good Manufacturing Practices (GMP) and uphold the standards of the Quality Management System (QMS)

Monitor processes for adherence to established procedures/regulatory compliance

Compiles, reviews, and completes production batch records, including raw and test data results, in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained

File and maintain batch records in accordance with GMP and internal procedures

Creates, adjusts and maintains filing systems for current and archived product master records (PMR), product history records (PHR), and batch records

Maintain process window and control plan log. Ensure updates are made per the review frequency

Organize completed inspection records with the production records

Manages and organizes inbound and outbound product documentation

Processes document change requests

Prepare Certificates of Analysis (CoA) in an efficient and timely manner. Assure that all customer specific requirements are satisfied

Generate C of A upon receipt of product release authorization

Retain all results from outside laboratory testing

Assist in the documentation and resolution of non-conformances and escalate quality concerns as needed

Write/revise documents, as necessary, and in accordance to good documentation practices

Assist in the generation and resolution of corrective and preventive action plans (CAPAs) as needed

Assist in 2ndand 3rd party audits

Act as a backup to the Document & Data Control Coordinator

Any other duties as assigned

Qualification

Document ControlManufacturing PracticesQuality Management SystemMicrosoft OfficeSelf-directedQuality Control KnowledgeCommunication SkillsDetail OrientedTeamwork