QA Stability Specialist at PACA in Eden Prairie, Minnesota

Job Description:

Apex International is a dynamic, high-quality manufacturer of personal and home care products with an extensive range of capabilities in OTC, cosmetic, and natural products. Apex is a leader in contract manufacturing because of its: • Measurable advantage in quality • Commitment to Lean Manufacturing and continuous improvement • Financial Strength as a privately held, single-owner company • Employees that are great at customer focus and problem-solving

Job Responsibilities and Duties: (Percentages = priority and approximate time focus)
1. Establishes and coordinates the product stability program to ensure all activities are performed. 45%
• 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.
• Monitors and maintains stability chambers and ensures proper documentation of all associated activities (e.g. excursions, deviations).
• 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. 35%
• Prepares stability time-point, annual, and end-of-study reports as required.
• Accurately records results as well as additional observations.
• 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. 10%
• Accurately creates monthly Key Quality Incident (KQI) in an accurate and timely way.
• Evaluate stability systems in manner that identifies ways to enhance stability system predictability, robustness, and communication.
• Provides conclusions and recommendations based upon stability results.

4. Understand and maintain a culture of “lean action” within the department so that we live 5%
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 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

5. Perform other work as assigned. 5%

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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