Quality Document Control & Training Specialist

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

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