Stability Coordinator

$50,000 - $110,000/Yr

McGuff Family of Companies - Santa Ana, CA

Full-time - Mid Level

Santa Ana, CA

About the position

The Stability Coordinator at McGuff Pharmaceuticals, Inc. is responsible for managing and overseeing stability studies for pharmaceutical products to ensure compliance with regulatory standards. This role involves collaboration with cross-functional teams and third-party contract labs to maintain the integrity of stability data, facilitate product development, and ensure timely testing and reporting of stability studies. The position requires a strong commitment to safety, quality, and customer service, while ensuring compliance with cGMP requirements and providing technical input to quality control and quality systems.

Responsibilities

• Manage and oversee stability studies for pharmaceutical products.
• Collaborate with cross-functional teams and third-party contract labs.
• Initiate stability protocols and maintain stability inventory schedules.
• Ensure timely testing of products and compile stability reports.
• Trend data across the shelf-life of products.
• Author stability protocols prior to the initiation of stability studies.
• Plan, organize, and manage stability studies in accordance with ICH and FDA guidelines.
• Coordinate the scheduling and execution of stability testing internally and at third-party labs.
• Ensure accurate and timely documentation of stability data and maintain stability databases.
• Review and analyze stability data to identify trends and report findings to stakeholders.
• Prepare stability reports and participate in regulatory submissions as needed.
• Train and mentor team members on stability testing protocols and regulatory requirements.

Requirements

• Bachelor of Science degree in a related field or comparable experience.
• 4-6 years of related industry experience and hands-on instrumental analysis.
• Knowledge of cGMPs, USP, and FDA regulations related to stability programs.
• Proficient in analytical laboratory instrumentation (HPLC, UPLC, etc.).
• Experience with statistical techniques and sampling plans.
• Strong critical thinking and troubleshooting skills.
• Proficient with Microsoft Office and related software.

Nice-to-haves

• Experience with Waters ARC HPLC/UPLC and Empower 3 software system.
• Knowledge of FDA cGMP and CFR requirements.
• Experience in training and mentoring junior staff.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Vision insurance