QA Stability Specialist

About the role

The QA Stability Specialist is responsible for establishing and coordinating the product stability program, ensuring that all activities are performed efficiently and accurately. This role involves developing stability studies and protocols, monitoring stability chambers, and ensuring compliance with regulatory requirements.

Responsibilities

• Develop stability studies and protocols to meet customer stability requirements.
• Determine sample stability requirements and oversee study completion.
• Monitor and maintain stability chambers and document all associated activities.
• Implement a visual system to ensure 100% compliance in pull schedule, testing, and reporting.
• Provide and maintain accurate documentation to meet regulatory (ICH) and client requirements.
• Accurately record results and additional observations.
• Communicate with R&D and Quality Control about results, trends, conclusions, and recommendations.
• Utilize data to focus improvement efforts to meet customer and regulatory regulations.
• Create monthly Key Quality Incident (KQI) reports accurately and timely.
• Evaluate stability systems to enhance predictability, robustness, and communication.
• Provide conclusions and recommendations based on stability results.
• Maintain a culture of 'lean action' within the department.
• Implement and maintain standards and processes to eliminate waste.
• Apply 'lean tools' to permanently implement improvements.
• Institutionalize 5-S in all aspects of the department (Sort, Straighten, Shine, Standardize, Sustain).

Qualifications

• Bachelor's Degree in Chemistry, Biology, or related scientific discipline preferred.
• Experience in pharmaceutical, cosmetics, personal care, or food manufacturing environments.
• Strong ability to prioritize and manage multiple tasks simultaneously.
• Excellent organizational and time-management skills.
• Detail-oriented with a commitment to accuracy and quality.

Work Environment

The position is based onsite in Eden Prairie, MN, and follows a standard 1st shift schedule. It is a full-time role with flexibility to meet business and customer needs. Occasional overtime may be required, including up to 5-10 additional hours per week during periods of increased workload. The work environment is primarily indoors, with exposure to various fragrances and product scents. The role requires standing and walking occasionally, performing repetitive hand and wrist movements, and working at a computer workstation for extended periods. A dynamic, fast-paced environment requires adaptability to changing priorities.

Pay

The pay range for this position is $29.80 - $36.00/hr. Individual compensation offered will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)