ProQualityNetwork is hiring: Technical Writer in Elizabethtown

Title: Technical Writer in Regulated Industry

Location: Elizabethtwon, PA, USA

Work Setup: 100% Onsite (Local Candidates Preferred)

Start Date: January 2024

Job Summary

Are you an experienced Technical Writer with a passion for creating precise, impactful documentation in regulated industries? Join our client's team and play a critical role in producing documentation that ensures compliance and supports operational excellence. This opportunity is perfect for individuals with expertise in pharmaceutical manufacturing practices, facility and equipment qualifications, and data collection within Quality Management Systems (QMS).

Key Responsibilities

1. Documentation Development:

• Write, review, and update technical documents such as:
• Standard Operating Procedures (SOPs)
• Work Instructions (WIs)
• Technical manuals
• Training materials
• Ensure all documentation adheres to regulatory requirements, quality standards, and Good Documentation Practices (GDPs).

2. Data Collection and Analysis:

• Gather relevant information from across the Quality Management System (QMS).
• Analyze and synthesize technical data to create accurate and comprehensive reports.
• Write detailed periodic qualifications and validation review reports.

3. Collaboration and Communication:

• Partner with cross-functional teams, including:
• Engineering
• Quality Assurance
• Manufacturing
• Regulatory Affairs
• Translate technical information into clear, user-friendly content for diverse audiences.

4. Quality Assurance:

• Conduct reviews to ensure documents are accurate, clear, and compliant.
• Manage document workflows and maintain version control using electronic systems.

Educational & Experience Requirements

• Bachelors degree in a relevant field (e.g., English, Communications, Engineering, or Science).
• At least 3 years of experience as a Technical Writer in regulated industries.
• Proficiency in tools like Microsoft Office Suite, Adobe Acrobat, and electronic document management systems.

Preferred Qualifications

• Experience in pharmaceutical manufacturing or consumer healthcare.
• Familiarity with facility and equipment qualification processes.
• Hands-on experience applying regulatory guidelines and GDPs.
• Strong skills in:
• Technical writing and editing
• Attention to detail
• Effective communication
• Time management and multitasking

Why Apply?

This role offers an incredible opportunity to work on meaningful projects in a dynamic and collaborative environment. Your contributions will directly impact quality and compliance in the regulated industry, making a real difference.