Quality Documentation and Labeling Associate Job Plymouth area,Minnesota USA,Quality Assurance

Quality Documentation and Labeling Associate

Full Time Clerical Plymouth, MN, US

2 days ago Requisition

Salary Range: $26.36 To $36.38 Hourly

Team :
Quality

History:

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Team :
Quality

History:

Working as one to help many. WHY THIS ROLE MATTERS

This role is responsible for maintaining the document control system and coordinating product and packaging labeling activities in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and applicable company procedures. This is an entry-level position well-suited for a detail-oriented individual seeking to build a career in quality systems.

The Quality Documentation and Labeling Associate supports Pro Med's mission and values by applying and reinforcing the company's brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

WHAT YOU’LL ACHIEVE

As the Quality Documentation and Labeling Associate, you'll ensure that Pro Med's controlled documents and product labeling remain accurate, current, and fully compliant with cGMP and FDA requirements - giving Operations, Regulatory Affairs, and Marketing a reliable system to work from and giving auditors clear evidence of control. This is achieved through the following groups of tasks:

Document Control

Issue, distribute, and archive controlled documents including SOPs, work instructions, batch records, and quality forms in accordance with the document control procedure.
Process document change control requests, track revision history, and ensure documents are reviewed and approved by appropriate stakeholders within established timelines.
Maintain the document management system to ensure accuracy, accessibility, and version integrity of all controlled documents.
Conduct periodic document reviews and notify document owners of upcoming expiration dates.
Support internal and external audits by retrieving controlled documents and demonstrating compliance with document control procedures.

Labeling

Coordinate the creation, review, revision, and approval of product labels and packaging artwork in compliance with FDA 21 CFR and applicable regulatory requirements.
Maintain labeling master files and ensure that only current, approved label versions are released for use.
Perform label reconciliation activities and support the investigation of labeling discrepancies or errors.
Collaborate with Operations, Regulatory Affairs, and Marketing to ensure label content accuracy prior to printing and distribution.
Assist with label change management activities resulting from formulation, regulatory, or branding updates.

Other Responsibilities

Identify and escalation gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager.
Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities.
Support the implementation of regulatory changes and quality system improvements as…