Quality Assurance Specialist (Morrisville)

Description :

• Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.
• Responsible for performing inspection and disposition of raw materials and components by :
• Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
• Obtaining Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
• Reviewing and verifying all incoming documentation to confirm that materials meet defined testing specifications and quality standards.
• Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
• Archiving finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.
• Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.
• Complete assigned training and tasks within required timelines, represent the Quality function in cross-functional meetings, and provide feedback to the team as needed.
• Provide quality oversight and compliance guidance in accordance with company procedures and standards outlined in the SMPA Quality Management System.
• Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.
• Responsible for providing QA review / approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
• Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
• This role is an on-site position, scheduled Monday through Friday, primarily supporting GMP operations. The standard working hours are from 8 : 00 AM to 4 : 00 PM; however, flexibility may be required based on business needs.

Qualifications :