Quality Control Stabilities Associate

Job Purpose

The Quality Control Stabilities Associate for Mikart, LLC is responsible for the overall maintenance of stability information including scheduling, assigning lot expirations, and housing results for each product formulation. The individual in this position must also provide for the storage, under appropriate conditions, and subsequent submission of stability samples to the appropriate laboratory facility.

Essential Job Functions

• Prepare and maintain written stability protocols for each product formulation.
• Review packaging masters to schedule products for stability testing and request retainers as required.
• Maintain a log of packaging lots for each product formulation.
• Confirm all product expiry periods on packaging masters.
• Pull stability samples and submit to the appropriate testing facility.
• Report problematic stability results to Stability Management.
• Prepare and maintain annual retainer inspection records.
• Maintain inventory of retainers and stability samples, including annual physical inventory of controlled substances.
• Prepare outdated retainers and stability samples for destruction.
• Monitor performance and maintenance of stability storage areas.
• Prepare, update, and maintain Stability Summary Forms. Enters data generated by analysts into the computer. Forward updated Stability Summary Forms to respective customer contacts.
• Submit Stability Summary Forms to Finance for Stability billing.
• Assists in maintaining, filing, and forwarding of all documentation generated by the Stability department. Maintain a log of Stability Billing Records.
• Update and maintain the Stability schedule for all products requiring stability testing.
• Prepare and ship samples requiring outside Stability testing.
• Facilitating customer complaint inspections of Retain samples.
• Prepare and maintain Regression analyses for Annual Product Reviews.
• Provide for the maintenance of all retainer and stability storage areas.

Key Characteristics

• The individual selected for the role as a stabilities associate will require to be organized, conscientious, and be capable of performing the job responsibilities to the specified standard.
• Team player.
• Very strong work ethic.
• Able to follow clear instructions.
• Attention to detail.
• Robust communication skills (oral and written).
• Robust computer skills.
• Flexible work hours.

Education and Qualifications

• Bachelor’s degree or equivalent required.
• Other combination of education and applicable experience considered.
• Fluency in the English language is required.

Physical Demands

• Lifting, walking, standing, repetitive hand motions and attentiveness required.
• Occasional heavy lifting or moving required.
• The ability to gown and work successfully in a laboratory environment, if necessary.
• The ability to carry and lift overhead at least 25 pounds.

This job description is not all-inclusive; other duties may be performed as assigned.

Salary: Mikart, LLC offers a competitive compensation program and comprehensive benefits package to our employees.