Stability & Quality Data Specialist

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

Benefits offered by this job

Medical, Rx, Dental and Vision

Company Paid Disability

Company Paid Life Insurance

Flexible Spending Account

401(k) with company match

Employee Assistance Program

Job summary

Apex International in Eden Prairie, MN is seeking a detail-oriented Stability Specialist to join our Quality team. The role focuses on establishing, maintaining, and improving product stability programs to ensure regulatory compliance and reliable data.

The Stability Specialist will coordinate stability studies, manage chambers and samples, prepare reports, analyze trends, and support audits. Strong documentation, GMP/ICH knowledge, and cross-functional collaboration are essential.

Qualifications

• Experience in product stability support or a chemistry lab is preferred.
• Knowledge of ICH stability guidelines and GMP is preferred.
• Strong organizational skills and attention to detail are required.

Responsibilities

• Establish and coordinate product stability programs to meet requirements.
• Develop stability studies and protocols aligned with customer/regulatory needs.
• Coordinate sample stability, testing, and reporting milestones.
• Maintain stability chambers, inventories, and study records.
• Prepare stability reports and ensure audit readiness.
• Analyze stability data and communicate results to stakeholders.
• Support quality metrics and continuous improvement initiatives.
• Promote lean practices and 5S within the department.

Skills

Attention to detail

Documentation accuracy

Cross-functional collaboration

Analytical thinking

Project prioritization

Education

Bachelor's degree in Chemistry, Biology, or related field

Tools

Microsoft Office (Excel, Word, Outlook)

Job description

Apex International in Eden Prairie, MN is seeking a detail-oriented Stability Specialist to join our Quality team. The role focuses on establishing, maintaining, and improving product stability programs to ensure regulatory compliance and reliable data.

The Stability Specialist will coordinate stability studies, manage chambers and samples, prepare reports, analyze trends, and support audits. Strong documentation, GMP/ICH knowledge, and cross-functional collaboration are essential.