QA Stability Specialist with Apex International in Eden Prairie, MN - Apex International

At Apex International, we pride ourselves on being a high-quality manufacturer of over the counter personal care, and household products. We create collaborative partnerships with customers ranging from global Fortune 100 companies to entrepreneurial start-ups.

We are currently seeking a QA Stability Specialist at our Eden Prairie location. This non-exempt, Monday-Friday daytime role will report to the Quality Manager and establish and maintain a world-class stability program that generates optimum product stability data that exceeds customer needs.

Job Responsibilities and Duties

1. Establishes and coordinates the product stability program to ensure all activities are performed.
   1. Develops stability studies/protocols which meet customer stability requirements. Determines sample stability requirements, develops stability protocols/reports, performs study set-up, and oversees study completion.
   2. Monitors and maintains stability chambers and ensures proper documentation of all associated activities (e.g. excursions, deviations).
   3. Implements visual system to ensure 100% compliance in pull schedule, testing, and reporting.
2. Provides and maintains accurate documentation to meet regulatory (ICH) and client requirements.
   1. Prepares stability time-point, annual, and end-of-study reports as required.
   2. Accurately records results as well as additional observations.
   3. Communicates with appropriate R&D and Quality Control with regards to results, trends, conclusions, problems and recommendations to resolve issues in a timely manner.
3. Utilizes data to focus improvement efforts so customer and regulatory regulations are met.
   1. Accurately creates monthly Key Quality Incident (KQI) in an accurate and timely way.
   2. Evaluate stability systems in manner that identifies ways to enhance stability system predictability, robustness, and communication.
   3. Provides conclusions and recommendations based upon stability results.
4. Understand and maintain a culture of "lean action" within the department so that we live lean better than any organization.
   1. Implement and maintain standards and processes that eliminate waste throughout the department.
   2. Apply and utilize "lean tools" to permanently implement improvements.
   3. Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)
5. Perform other work as assigned.

Qualification and Skill Requirements

Prior Experience

• Prefer experience in product stability support or chemistry lab environment such as pharmaceutical, cosmetics, personal care, food processing, etc.
• Preference provided to experience with ICH stability programs.

Knowledge Requirements

• To be effective, this position requires the ability to multitask, demonstrate a sense of urgency, and the ability to organize.
• Lab experience normally acquired through a 4-year college degree in Chemistry, Biology or related science discipline and/or equivalent experience is preferred.

Additional Information

Apex International's dynamic nature, unwavering commitment to quality, implementation of Lean Manufacturing practices, financial strength, unwavering focus on customer satisfaction and problem-solving employees have propelled us to become a prominent industry leader in contract manufacturing for the personal and home care sector.

As a leader in contract manufacturing, Apex stands out due to:

1. Unrivaled commitment to quality: Apex sets itself apart with its measurable advantage in delivering products of the highest quality standards.
2. Emphasis on Lean Manufacturing and continuous improvement: Apex is dedicated to implementing Lean Manufacturing practices, constantly seeking ways to optimize processes and enhance efficiency.
3. Financial Strength as a privately held, single-owner company: As a privately held company with strong financial stability, Apex ensures reliability and long-term partnership opportunities.
4. Customer-focused and problem-solving employees: Apex boasts a team of highly skilled and dedicated employees who excel in customer service and possess exceptional problem-solving abilities. Our commitment to meeting customer needs is unparalleled.

Apex International Inc. is an equal-opportunity Employer.