Quality Assurance Specialist

Responsibilities

• Congducting evaluation and disposition of clinical supply materials, ensuring compliance with all relevant policies, procedures, and cGMP regulations.
• Coordinating and supporting the development of procedures, processes, and quality improvements to enhance our operations.
• Initiating and completing projects aimed at improving process performance, including continuous process improvements and value capture projects.
• Assisting in the coordination of significant quality events, providing fact-finding and investigation support.
• Collaborating with cross-functional teams to ensure robust processing, continuous improvement, and effective team building.
• Championing the use of Lean Six Sigma (LSS) and other tools in problem-solving and operational activities.

Qualifications

• Bachelor's Degree or higher in engineering, science, or related discipline from an accredited college/university.
• Minimum 2 years of experience in the Pharmaceutical or equivalent industry in a GMP-related field, including Technical, Engineering, Quality, or Operations.
• Familiarity with batch disposition activities is essential.
• Strong problem-solving, collaboration, and written and oral communication skills.
• Ability to independently manage multiple priorities and work efficiently in a dynamic environment.
• Demonstrated teamwork skills and the ability to work independently when required.
• Basic understanding of Microsoft applications, such as MS Excel, Outlook, and/or MS Access.
• Attention to detail, flexibility, and an awareness of production and quality control challenges.

Pay

Salary Range is dependent upon experience

Benefits

Comprehensive benefits package