Quality Document Control & Training Coordinator

Polyzen; Apex (NC); On-site; USD 45,000 - 60,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with excellent company match

Health Insurance with multiple plans

Job summary

Polyzen in Apex, NC is seeking a Document Control and Training Coordinator for a 1st shift (Monday–Friday 8:00 am–5:00 pm). On-site role focused on managing the QMS documentation system and training program in support of FDA 21 CFR Part 820, ISO 13485, and ISO 9001 guidelines.

You will partner with management to drive compliance with customer requirements and internal procedures, maintain controlled documents, support audits, and provide metrics.

Qualifications

• High School Diploma or GED; or equivalent experience in regulated industry.
• 2–3 years in ISO or FDA-regulated environment.
• Experience developing or maintaining a QMS or controlled documents.
• Strong communication, attention to detail, and ability to work with minimal supervision.
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel).

Responsibilities

• Implements and maintains the QMS documentation system and processes while ensuring compliance with applicable standards and customer requirements.
• Monitor the Document Change Control Request process and ensure it aligns with stated Work Instructions.
• Authors and updates controlled documents and specifications, including SOPs, WIs, and Internal Specifications, maintaining revision control records.
• Ensures control of quality records and retention per procedures.
• Initiates periodic review of controlled documents per company procedure.
• Manages training program and records, conducts orientation training for Quality.
• Assists in internal/external audits and supplies documents as applicable.
• Provides metric data as requested.
• Maintains off-site storage of records and related tasks.
• Performs other activities/projects as requested by RA/QA Management.

Skills

Effective communication

Attention to detail

Prioritization

Independent worker

Team collaboration

Education

High School Diploma or GED

Tools

Microsoft Office Suite

Job description

Polyzen in Apex, NC is seeking a Document Control and Training Coordinator for a 1st shift (Monday–Friday 8:00 am–5:00 pm). On-site role focused on managing the QMS documentation system and training program in support of FDA 21 CFR Part 820, ISO 13485, and ISO 9001 guidelines.

You will partner with management to drive compliance with customer requirements and internal procedures, maintain controlled documents, support audits, and provide metrics.