Entry-Level Quality Documentation & Labeling Associate

ProMed Molded Products, Inc.; Plymouth, Northern (MN, KY); Hybrid; USD 75,532,000 - 104,243,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Job summary

ProMed Molded Products, Inc. in Plymouth, MN is seeking a Quality Documentation and Labeling Associate to support document control and labeling activities in a CGMP/FDA-compliant environment.

You will maintain controlled documents, manage labeling master files, and coordinate with Operations, Regulatory Affairs, and Marketing to ensure accuracy and compliance, while supporting audits and continuous quality improvements.

Qualifications

• Experience in quality documentation and/or learning management systems.
• Strong interpersonal, written, and verbal communication skills.
• Ability to establish collaborative relationships with various departments to deliver on quality commitments.
• Strong computer skills, including Microsoft Word and quality systems software.
• Attention to detail and commitment to data integrity and accuracy in all quality records.
• Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements.

Responsibilities

• Maintain controlled documents including SOPs, work instructions, batch records, and quality forms.
• Coordinate labeling activities, review packaging artwork, and ensure FDA/21 CFR compliance.
• Support internal/external audits by retrieving controlled documents and demonstrating compliance.
• Identify and escalate gaps or compliance risks within the QMS to QA Manager.
• Input data to create and revise material and method masters in the ERP system.

Skills

Quality documentation

Labeling

Document control

Attention to detail

Data integrity

Microsoft Word

Quality systems software

Education

High School Diploma or GED

Tools

ERP system

Quality systems software

Job description

ProMed Molded Products, Inc. in Plymouth, MN is seeking a Quality Documentation and Labeling Associate to support document control and labeling activities in a CGMP/FDA-compliant environment.

You will maintain controlled documents, manage labeling master files, and coordinate with Operations, Regulatory Affairs, and Marketing to ensure accuracy and compliance, while supporting audits and continuous quality improvements.