Stability QA Specialist — Data-Driven & Lean Quality

Apex International; Eden Prairie (MN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Company-paid disability

Company-paid life insurance

401(k) with company match

Job summary

Apex International in Eden Prairie, MN, seeks a detail-oriented Stability Specialist to join our Quality team. You will establish, maintain, and improve stability programs to meet regulatory requirements and provide reliable performance data.

You will develop stability studies, manage chambers, document deviations, and prepare reports in line with ICH, GMP, and customer specifications. The role emphasizes cross-functional collaboration with R&D, QA, Manufacturing, and Regulatory.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related discipline preferred or equivalent experience.
• Experience with ICH stability programs and GMP preferred.
• Strong analytical and documentation skills.

Responsibilities

• Establish and coordinate product stability programs to ensure all required activities are completed.
• Develop stability studies and protocols meeting customer, regulatory, and internal requirements.
• Determine sample stability requirements and coordinate study setup, monitoring, testing, and completion.
• Maintain stability pull schedules and ensure testing and reporting milestones are completed on time.
• Oversee product stability studies from initiation through final reporting.
• Manage and maintain stability chambers and supporting systems.
• Monitor stability chamber performance and environmental conditions.
• Ensure proper documentation and resolution of chamber excursions, alarms, deviations, and corrective actions.

Skills

Stability program management

Data analysis

Technical reporting

Cross-functional collaboration

Lean methodologies

Education

Bachelor's degree in Chemistry or related field

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

Apex International in Eden Prairie, MN, seeks a detail-oriented Stability Specialist to join our Quality team. You will establish, maintain, and improve stability programs to meet regulatory requirements and provide reliable performance data.

You will develop stability studies, manage chambers, document deviations, and prepare reports in line with ICH, GMP, and customer specifications. The role emphasizes cross-functional collaboration with R&D, QA, Manufacturing, and Regulatory.