Manager Quality - Stability

As the Stability Manager at Vi-Jon's Smyrna facility, you will play a critical role in ensuring the quality and integrity of our over-the-counter (OTC) drug and cosmetic products. You will lead the stability testing program, collaborating closely with the Quality Control, Quality Assurance and Research & Development departments to manage the stability chemists, review the data, and provide accurate and timely stability reports. Your expertise will contribute to maintaining the safety, efficacy, and regulatory compliance of our products.

Responsibilities:

• Oversee and manage the stability testing program for Vi-Jon's over-the-counter drug products.
• Collaborate with the Quality Assurance, Quality Control, and Research & Development departments to develop and implement stability protocols, schedules, and testing methodologies.
• Lead a small team responsible for performing stability sample testing
• Ensure stability reports are issued in a timely manner
• Conduct ongoing stability studies in accordance with regulatory guidelines, ICH requirements, and internal procedures.
• Coordinate sample collection, storage, and testing activities to ensure accurate and reliable results.
• Analyze stability data and provide regular reports to the Quality Assurance and Research & Development departments, identifying trends and potential issues.
• Work closely with cross-functional teams to address any stability-related concerns and provide recommendations for product improvements or adjustments.
• Ensure compliance with regulatory requirements and industry standards, including ICH, related to stability testing and reporting.
• Participate in regulatory audits and inspections, providing necessary documentation and information related to stability studies.
• Stay updated on industry trends, best practices, and regulatory changes in stability testing and related areas.

Qualifications:

• Bachelor's or degree in Chemistry, Pharmaceutical Sciences, or a related field.
• A minimum of 5 years of experience in stability testing and management within the pharmaceutical or OTC drug industry.
• Strong understanding of regulatory requirements and guidelines related to stability testing (ICH, FDA, etc.).
• Proficiency in data analysis and reporting tools.
• Excellent communication and interpersonal skills.
• Detail-oriented mindset with a focus on accuracy and quality.

Work Environment: Physical Setting: Office jobs are typically situated in climate-controlled, indoor environments. The workspace is usually equipped with desks, computers, chairs, and other necessary office equipment. Time may be spent in a stability chamber pulling samples. This includes squatting, bending, and lifting.