GMP Document Control Specialist – Entry Level

MGS Manufacturing; Town of Richfield (WI); On-site; USD 38,000 - 52,000; Full time

Job summary

MGS Mfg. Group is seeking a Document Control Specialist for our Richfield, WI molding facility. You will manage company documents, ensure accuracy, quality, and integrity, and prepare CoAs for customers in a timely manner.

Responsibilities include maintaining filing systems, reviewing batch records, ensuring GMP/GDP compliance, and supporting internal audits. Strong attention to detail and teamwork are essential for success.

Qualifications

• High school diploma or equivalent is required.
• 2 to 4 years of experience and/or training, or equivalent combination of education and experience.
• Experience in working with team.
• Good working understanding of Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to prioritize, multitask, and manage time well.
• 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.

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.
• 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 elevate 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 2 nd and 3 rd party audits.
• Act as a backup to the Document & Data Control Coordinator.
• Any other duties as assigned.

Skills

Teamwork

Time management

Detail-oriented

Communication skills

Self-motivated

Education

High School/GED

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

MGS Mfg. Group is seeking a Document Control Specialist for our Richfield, WI molding facility. You will manage company documents, ensure accuracy, quality, and integrity, and prepare CoAs for customers in a timely manner.

Responsibilities include maintaining filing systems, reviewing batch records, ensuring GMP/GDP compliance, and supporting internal audits. Strong attention to detail and teamwork are essential for success.