Quality Documentation and Labeling Associate
About The Position
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 ProMed'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.
Requirements
- 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.
- High School Diploma or GED.
- 2+ years of work experience in quality or document control.
- Must be very detail-oriented and accurate with data entry.
- Speaks and reads English fluently.
Responsibilities
- 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.
- 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.
- Identify and escalate 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.
Benefits
- 401k with company match
- Profit Sharing Program
- Medical Insurance
- Health Savings Account/Flexible Spending Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Paid Family Medical Leave and Long-Term Disability Insurance
- Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
- Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
