Document Control and Training Coordinator (Monday-Friday 8:00 am-5:00 pm)

Solesis; Apex (NC); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Paid Time Off

Annual Bonus

401(k) with match

Health Insurance

Disability insurance

Job summary

Polyzen in Apex, NC is seeking a Document Control & Training Coordinator for a 1st shift, Monday–Friday 8:00 am–5:00 pm. You will ensure the effectiveness and compliance of the document management system and training program in support of FDA 21 CFR Part 820, ISO 13485 and ISO 9001, partnering with the Management Team to drive compliance with customer requirements and internal procedures.

Responsibilities include maintaining QMS documentation and controlled documents, SOPs and WIs, managing

Qualifications

• High School Diploma or GED required with applicable experience.
• 2–3 years of experience in ISO or FDA-regulated environments.
• Hands-on experience developing or maintaining a QMS or controlled document system.
• Effective communication, task prioritization, and attention to detail.
• Ability to work independently or in a team.
• Proficiency with GMP, GDP and MS Office tools.

Responsibilities

• Maintains QMS documentation and controlled documents, SOPs, and WIs.
• Ensures quality records retention and compliance with procedures.
• Initiates and maintains periodic review of controlled documents.
• Manages training program and records; conducts orientation for Quality.
• Supports release of documents and collaboration with RA/QA.
• Assists internal/external audits and provides required documents.

Skills

GMP knowledge

GDP knowledge

MS Office

Regulatory experience

Education

High School Diploma or GED

Job description

Document Control and Training Coordinator (Monday-Friday 8:00 am-5:00 pm)

Job Category: Quality Control

Requisition Number: DOCUM002573

• Posted : July 31, 2026


• Full-Time


• On-site

Locations

Showing 1 location

Apex, NC
1041 Classic Road
Apex, NC 27539, USA

Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

As the Document Control & Training Coordinator, you will ensure the effectiveness and compliance of the document management system and training program, in support of FDA 21 CFR Part 820, ISO 13485, and ISO 9001 guidelines and regulations. This role will partner with the Management Team to drive compliance with customer requirements, external standards, and internal specifications/procedures.

What you will do:

• Implements and maintains the Quality Management System (QMS) documentation system and associated processes while ensuring compliance with applicable standards, regulatory and customer requirements, and overall protection of company intellectual property.


• Monitor the Document Change Control Request process and ensures the process is performing as stated in the applicable Work Instruction (WI).


• Authors and updates controlled documents and specifications, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and Internal Specifications, following established processes to ensure revision control records are maintained.


• Assures control of quality records (including records retention) are compliant with procedures and applicable Work Instructions.


• Initiates and maintains periodic review of controlled documents per company procedure.


• Manages training program, granting employees access and assuring all training records are current to employees’ curriculum, conducts orientation training for Quality.


• Work with Quality Management to ensure that documents are released and become effective.


• Assists in internal/external audits and supplying documents as applicable.


• Supplies applicable Metric Data as requested.


• Maintains off-site storage of records including requesting pickups, ordering boxes, etc.


• Performs other activities and other projects as requested by RA/QA Management.

Who you are:

• High School Diploma or GED Equivalent; in the absence of a diploma or 4-year degree, applicable years of experience are required.


• Two (2) to three (3) years of relevant work experience in an ISO or FDA-regulated environment.


• Must have hands-on experience developing or maintaining a QMS or controlled document system in a regulated industry.


• Effective communication skills, ability to prioritize tasks, and attention to detail.


• Ability to work independently under minimal supervision and/or as part of a team.


• Sound knowledge of GMP and GDP requirements.


• Proficiency with Microsoft Office Suite including Word, PowerPoint, and Excel.


• Generous Paid Time Off


• Annual Bonus


• 401(k) with excellent company match


• Health Insurance with multiple plans to choose from


• Paid Short Term and Long Term Disability

Qualifications

Skills

Behaviors

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Motivations

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Education

Experience

Licenses & Certifications

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.