QA Stability 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

At Apex International, we take pride in our commitment to manufacturing high-quality OTC, personal care, and household products. We strive to build collaborative partnerships with a diverse range of customers, including global Fortune 100 companies and entrepreneurial start-ups.

We are seeking a detail-oriented and organized Stability Specialist to join our Quality team.

Location: Eden Prairie, MN

The Stability Specialist will contribute to the success of our customers and operations by establishing, maintaining, and continuously improving product stability programs that ensure regulatory compliance, support customer requirements, and provide reliable product performance data.

Job Responsibilities and Duties:

1. Establish and coordinate product stability programs to ensure all required activities are completed.

   • Develop stability studies and protocols that meet 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.

2. 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.
   • Maintain stability inventory, sample tracking, and study records.
   • Support chamber qualification, maintenance, and ongoing compliance activities.

3. Maintain accurate stability documentation and reporting.

   • Prepare stability time-point reports, annual reports, and end-of-study reports.
   • Accurately document testing results, observations, conclusions, and recommendations.
   • Ensure documentation meets ICH guidelines, customer specifications, and internal quality requirements.
   • Maintain organized and audit-ready records to support customer and regulatory audits.

4. Analyze stability data and communicate results.

   • Evaluate stability trends and provide scientific conclusions regarding product performance.
   • Communicate results, concerns, trends, and recommendations to Research & Development, Quality Control, Operations, and other stakeholders.
   • Assist with investigations involving stability-related deviations, product performance concerns, or customer inquiries.
   • Provide recommendations to improve product performance and stability program effectiveness.

5. Support quality metrics and continuous improvement initiatives.

   • Accurately prepare and report monthly Key Quality Incident (KQI) metrics.
   • Analyze stability processes and identify opportunities to improve predictability, efficiency, and effectiveness.
   • Participate in corrective and preventive action activities as required.
   • Support internal audits, customer audits, and regulatory inspections when applicable.

6. Understand and maintain a culture of "lean action" within the department so that we live lean better than any organization.

   • Implement and maintain standards and processes that eliminate waste throughout the department.
   • Apply and utilize lean tools to permanently implement improvements.
   • Institutionalize and sustain 5S principles throughout the department (Sort, Straighten, Shine, Standardize, and Sustain).
   • Actively participate in continuous improvement projects and initiatives.

7. Provide cross-functional support to quality and laboratory operations.

   • Collaborate with R&D, Quality Control, Manufacturing, Regulatory, and Customer teams to ensure stability requirements are met.
   • Assist with customer requests and technical inquiries related to stability studies and product performance.
   • Support departmental projects, quality initiatives, and other business objectives as needed.

8. Other duties as assigned.

Qualification and Skill Requirements:

Prior Experience:

Experience in product stability support, quality control, quality assurance, or a chemistry laboratory environment is preferred. Experience within pharmaceutical, cosmetics, personal care, OTC, food processing, or related industries is highly desirable. Experience with ICH stability programs is preferred.

A Bachelor's degree in Chemistry, Biology, or a related scientific discipline is preferred; equivalent education and experience will be considered.

Knowledge Requirements:

To be effective, this position requires strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced laboratory environment. Candidates should possess knowledge of laboratory testing practices, stability study management, data analysis, quality systems, and technical documentation.

Knowledge of ICH stability guidelines, Good Manufacturing Practices (GMP), and regulatory requirements is preferred. Strong analytical, troubleshooting, communication, and problem-solving skills are required. The ability to work independently while collaborating effectively with cross-functional teams is essential.

Candidates must be capable of interpreting stability data trends, preparing technical reports, maintaining accurate records, and communicating findings and recommendations to internal stakeholders and customers.

Licenses and Certifications:

Relevant quality, laboratory, or scientific certifications are preferred but not required.

Technical Competencies:

• Strong attention to detail and documentation accuracy.
• Ability to organize, prioritize, and manage multiple projects simultaneously.
• Ability to analyze stability data and identify trends.
• Strong analytical and problem-solving abilities.
• Ability to read and follow written procedures, specifications, and work instructions.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications, including Excel, Word, and Outlook.
• Ability to collaborate effectively with cross-functional teams.
• Commitment to continuous improvement and lean methodologies.

Working Conditions:

• Primarily laboratory and office environment.
• Will be exposed to various fragrances which at times may be at elevated levels.
• Able to utilize stairways.
• Able to respond and adapt to changes in the work environment.
• Ability to work in a high-paced work environment.
• Occasional work outside normal business hours may be required based on stability schedules, customer demands, or business needs.

Benefits:

• Annual Salary of $60,000 - $75,000, depending on experience and qualifications.
• Medical, Rx, Dental and Vision Benefits.
• Company Paid Short-Term & Long-Term Disability.
• Company Paid Life Insurance.
• Optional Life Insurance for Employee, Spouse and Children.
• Flexible Spending Account Options for Child and Health Care.
• 401(k) Retirement Plan with Company Match.
• Employee Assistance Program.