Specialist I, QA Document Control

Role Summary

Create, format, revise and proofread controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

Responsibilities

• Create, format, revise, and proofread controlled documents such as Standard Operating Procedures (SOPs), forms, validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control.
• Enforce limited access restriction of secured controlled documents in the electronic and physical document locations.
• Process documents for approval signatures, official distributions, and obsoletion.
• Assist with maintaining inventory of on-site documentation.
• Assist with the maintenance of document retention and destruction schedules.
• Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

Qualifications

• Required: Experience — 1-2 years of experience with document management systems and software.
• Preferred: Compliance Requirements (ES) — The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
• Required: Competencies — Ability to follow the cGMP’s and procedures with great attention to detail.

Education

• High school diploma or equivalent required.

Skills

• Ability to follow cGMPs and procedures with great attention to detail.