Stability Coordinator

Job Details

Job Location: AVER - Grand Prairie, TX 75050

Position Type: Full Time

The Stability Coordinator is a critical role in Fruit of the Earth’s continued success. This position requires time management skills, attention to detail and the ability to work effectively under minimal supervision. Professionalism, flexibility, dependability and dedication are skills necessary for the day-to-day success of this position.

Key Responsibilities:

• Management and organization of the stability program
• Execution of stability protocols with minimal supervision.
• Interpretation and trending of stability data
• Responsible for writing stability protocols and reports.
• Ensure all stability testing is completed in a timely manner.
• Follow required protocols, practices and SOPs.
• Maintain stability chambers and data
• Maintain stability records
• Conduct appropriate investigations for discrepancies.
• Performs other duties and responsibilities as assigned by supervisor.

Necessary

Qualifications:

• Four-year college degree in Chemistry, Biochemistry, Microbiology, or related field required.
• Minimum of 2-5 years of stability experience.
• Thorough knowledge and hands-on experience with stability programs in a drug cGMP environment.
• Knowledge of cGMP, cGLP, OSHA, TDOH and FDA rules and regulations.
• Strong understanding of quality control processes.
• Strong organizational, interpersonal, written and oral communication skills.
• Strong technical writing skills
• Strong organizational skills
• Ability to interpret and trend analytical data.
• Ability to meet and monitor deadlines and prioritize work.
• Self-motivated and detail oriented.
• Strong computer skills including Microsoft Office Suite.
• Flexible ability to take on additional tasks as needed.

Additional

Preferred Qualifications:

• Experience with analytical equipment such as TOC, HPLC and FTIR.
• Experience in an OTC Drug Product manufacturing environment.
• Experience writing stability protocols and reports.