Document Control Specialist

About the role

MGS Mfg. Group is seeking a Document Control Specialist for our Richfield, WI molding facility. This role manages company documents, ensuring accuracy, quality, and integrity while adhering to record retention policies, batch record review, and efficient data retrieval. The specialist also prepares and submits Certificates of Analysis (CoA) to customers in a timely manner.

Responsibilities

• Know and follow all company safety rules, safe work practices, and standard operating procedures.
• Serve as a role model for safe work practices and behavior.
• 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 GMP and uphold Quality Management System (QMS) standards.
• Monitor processes for adherence to established procedures and regulatory compliance.
• Compile, review, and complete production batch records, including raw and test data results, efficiently and timely.
• Ensure observations/deviations are properly investigated and explained.
• File and maintain batch records in accordance with GMP and internal procedures.
• Create, adjust, and maintain filing systems for product master records (PMR), product history records (PHR), and batch records.
• Maintain process window and control plan log, ensuring updates per review frequency.
• Organize completed inspection records with production records.
• Manage and organize inbound and outbound product documentation.
• Process document change requests.
• Prepare Certificates of Analysis (CoA) efficiently and ensure all customer-specific requirements are satisfied.
• Generate Certificates of Analysis upon receipt of product release authorization.
• Retain all results from outside laboratory testing.
• Assist in documenting and resolving non-conformances and escalate quality concerns as needed.
• Write and revise documents in accordance with good documentation practices.
• Assist in generating and resolving corrective and preventive action plans (CAPAs) as needed.
• Assist in 2nd and 3rd party audits.
• Act as a backup to the Document & Data Control Coordinator.
• Perform any other duties as assigned.

Requirements

• High school diploma or equivalent is required.
• 2 to 4 years of experience and/or training, or equivalent combination of education and experience.
• Experience working in a team environment.
• Good working understanding of Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to prioritize, multitask, and manage time effectively.
• Excellent listening, oral, and written communication skills.
• Extremely detail-oriented.
• Self-directed, ability to work independently, and highly motivated.
• Quality Control/Assurance knowledge is preferred but not required.

About the company

MGS is a global provider of healthcare manufacturing solutions, combining robust end-to-end solutions with strong customer focus and seamless collaboration. We serve customers from 12 strategically located facilities worldwide, transforming challenges into innovations that improve lives.

Benefits

• Medical, dental, and vision insurance.
• 401K retirement plan.
• Disability and life insurance.
• Paid vacation and holidays.