Job Description

🚨Technical Writer – Quality / Validation

🔁 Contract-to-Direct Opportunity

Local to Bethlehem, PA only

❌ No C2C | No Sponsorship

Summary:

Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.

Key Responsibilities:

• Oversight of Validation and Qualifications
• Oversight of Customer Complaints
• Document Control Activities
• Procedure Updates
• Write and Executed Qualification Documents
• Write Qualification Summary Reports
• Procedure Updates

Required Skills & Experience:

• Bachelor degree or higher in relevant scientific/quality assurance/technical field
• Technical writing/documentation experience in pharma or regulated manufacturing
• Experience with qualification and validation documentation
• Solid understanding of cGMP
• Excellent written communication and organizational skills
• Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems

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