Technical Writer
7 days ago
Company Overview: Paragon Staffing, LLC specializes in matching skilled professionals with reputable companies. As a Documentation Specialist, you will play a crucial role in maintaining accurate records and ensuring compliance with regulatory requirements.
Responsibilities:
- Create and revise documents used by production and quality departments.
- Capture pictures of the production process to incorporate into documentation.
- Enter data and information into the ER system, appropriate forms, and templates.
- Initiate and carry out document change requests.
- Interact with departments when questions arise.
- Assist with document control activities.
- Follow all DEA regulations per laboratory SOP.
- Prepare, maintain, and revise analytical methods and specifications as required.
- Track and assist with implementation of changes.
- Process change control requests as required.
- Validate and maintain calculations in controlled Excel spreadsheets and Empower.
- Research and gather information in a timely manner.
- Prepare, label, organize, and maintain files.
- Comply with FDA guidelines/Company Policies of Data Integrity.
- Other duties as assigned.
Requirements and Qualifications:
- Must have 2+ years of experience in Documentation.
- Computer experience a must. Excellent skills in Word, Excel, and Outlook.
- Excellent attention to detail.
- Dependable, positive attitude, and work ethic in a team environment.
- Satisfactory written/verbal communication, English required.
- Must have experience in packaging/manufacturing settings.
- Experience in pharmaceutical/lab environments.
- Quality control experience.
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