Stability Scientist II & Documentation Coordinator

ProQuality Network; United States; Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network seeks an Associate Scientist II / Stability Coordinator to support stability program activities in a cGMP environment. You will manage documentation flow, coordinate stability studies, and perform technical reviews to ensure accuracy and regulatory compliance.

You will develop stability work plans, maintain organized records for audit readiness, and contribute to continuous improvement while meeting milestones.

Qualifications

• Bachelor’s degree in Life Sciences or Physical Sciences.
• Strong proficiency in Word, Excel, Outlook.
• Ability to generate high-quality documentation compliant with SOPs.

Responsibilities

• Manage and track documentation flow (spreadsheets, reports, protocols, stability data).
• Author and support documentation such as: stability protocols, technical reports, CoA, SOPs.
• Perform parallel and technical review of documents to ensure accuracy, completeness, and regulatory compliance.
• Develop and execute stability work plans and schedules aligned with customer milestones and site metrics.
• Ensure all activities are performed in compliance with cGMP standards.
• Identify and support continuous improvement initiatives within stability and documentation processes.
• Maintain organized records and ensure audit readiness at all times.
• Comply with Environmental Health & Safety (EHS) requirements.
• Perform additional duties as assigned.

Skills

Documentation management

Regulatory documentation

Attention to detail

Multitasking

Communication

Problem-solving

Education

Bachelor's degree in Life Sciences/Physical Sciences

Tools

Microsoft Office

Job description

ProQuality Network seeks an Associate Scientist II / Stability Coordinator to support stability program activities in a cGMP environment. You will manage documentation flow, coordinate stability studies, and perform technical reviews to ensure accuracy and regulatory compliance.

You will develop stability work plans, maintain organized records for audit readiness, and contribute to continuous improvement while meeting milestones.