Quality Documentation & Labeling Specialist

ADP, Inc.; Plymouth (MN); On-site; USD 36,000 - 50,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account/FSA

Dental Insurance

Vision Insurance

Life Insurance

Paid Family Medical Leave and Long‑Ten

Long-Term Disability Insurance

Hospital Indemnity

Critical Illness

Accident

Identity Theft Protection

Pet Insurance

Job summary

ProMed is seeking a Quality Documentation and Labeling Associate in Plymouth, MN to maintain the document control system and coordinate product labeling in compliance with cGMP and FDA regulatory standards. This entry-level role offers exposure to audits and cross-functional collaboration with Operations, Regulatory Affairs, and Marketing.

The position requires a High School Diploma or GED and 2+ years in quality or document control, with fluency in English and meticulous data accuracy.

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

• Document Control: Issue, distribute, and archive controlled documents including SOPs, work instructions, batch records, and quality forms.
• 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 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 only current, approved label versions are released for use.
• Perform label reconciliation activities and support 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 directed.
• Assist in preparing responses to audit observations or regulatory findings that involve document or records management.
• Input data to create and revise material and method masters in the ERP system.

Skills

Quality documentation

Learning management systems

Interpersonal communication

Collaboration

MS Word

Quality systems

Attention to detail

Compliance

Education

High School Diploma or GED

Job description

ProMed is seeking a Quality Documentation and Labeling Associate in Plymouth, MN to maintain the document control system and coordinate product labeling in compliance with cGMP and FDA regulatory standards. This entry-level role offers exposure to audits and cross-functional collaboration with Operations, Regulatory Affairs, and Marketing.

The position requires a High School Diploma or GED and 2+ years in quality or document control, with fluency in English and meticulous data accuracy.