Associate Scientist II / Stability 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

Associate Scientist II / Stability Coordinator

Job Title: Associate Scientist II / Stability Coordinator

Schedule: Monday to Friday | 8:00 AM - 4:00 PM

Contract Type: 6-Month Contract (Temp-to-Hire) through ProQuality Network

Our client is seeking an Associate Scientist II / Stability Coordinator to support stability program activities within a cGMP-regulated environment. This role involves documentation management, stability study coordination, and technical review activities, requiring strong organization, attention to detail, and the ability to manage multiple priorities effectively.

• Manage and track documentation flow, including spreadsheets, reports, protocols, and stability data
• Author and support documentation such as:
• Stability protocols
• Technical reports
• Certificates of Analysis (CoA)
• Standard Operating Procedures (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

Qualifications

• Education: Bachelor's degree in Life Sciences or Physical Sciences (e.g., Biology, Chemistry, Biochemistry)
• Strong proficiency in Microsoft Office (Word, Excel, Outlook)
• Ability to generate and maintain high-quality documentation in compliance with regulatory standards and SOPs
• Strong organizational, time management, and multitasking skills
• Ability to interpret technical instructions in written, oral, or diagram formats
• Solid mathematical and scientific reasoning skills
• Excellent written and verbal communication skills
• Ability to work effectively under pressure and meet deadlines
• Proactive mindset with strong problem-solving and critical thinking abilities
• Ability to quickly learn and retain technical information

This is an excellent opportunity to build experience in stability programs, documentation, and regulatory compliance within a GMP environment, with strong potential for long-term growth.