Piper Companies is seeking a Quality Assurance Specialist to join a cutting-edge company that produces medicines, vaccines and biologic therapies. This position is located in West Point, Pennsylvania. The Clinical Supplies Quality Specialist position revolves around detailed working of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications.

Responsibilities of the Quality Assurance Specialist include:

• Evaluation and disposition of clinical supplies with assurance of following government regulations. Along with coordination of preparation of procedures and processes and quality improvements
• Assist in coordinating significant quality events including fact finding and investigation support
• Collaborate across IPT functional and business areas to ensure continuous improvement
• Actively using and championing the use of Lean Six Sigma (LSS) and production system- both used in day-to-day operational tasks

QUALIFICATIONS FOR THE QUALITY ASSURANCE SPECIALIST INCLUDE:

• Minimum 2 years’ experience in Pharmaceutical or industry Good Manufacturing Practice, or related field such as, engineering, quality or operations
• Familiarity with batch disposition activities
• Strong written and verbal communication skills, problem-solving skills, and demonstrated ability to work independently as well as in a team environment
• Attnetion to detail, flexibility, and awareness of production and quality control problems
• Bachelor’s degree in engineering, science or related field

• Evaluation and disposition of clinical supplies with assurance of following government regulations. Along with coordination of preparation of procedures and processes and quality improvements
• Assist in coordinating significant quality events including fact finding and investigation support
• Collaborate across IPT functional and business areas to ensure continuous improvement
• Actively using and championing the use of Lean Six Sigma (LSS) and production system- both used in day-to-day operational task