What are the responsibilities and job description for the Quality Assurance position at Akron Bio?
Job Description:
Akron Bio is transforming and expanding its capabilities, seeking highly motivated professionals to play a critical role in advanced therapy development and commercialization with high-quality industrial scale solutions.
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) and provide reports on performance with recommendations for improvement.
- Develop and maintain a current Quality Manual System Manual and Standard Operating Procedures (SOPs), guidelines, standards, and records.
- Control new and revised documents required for the operation of the QMS pursuant to the Quality Management System Manual.
- Establish quality standards and policies, perform organizational assessments, and manage projects in support of organizational goals and strategic objectives.
- Maintain a robust Quality Assurance Program addressing batch disposition, deviation, investigation, and corrective action.
- Develop staff and drive new approaches to Quality Assurance and Quality Management principles, theories, concepts, and techniques.
- Develop a system for management of technical product complaints.
- Review and approve SOPs, protocols, reports, and production batch records.
- Lead and manage day-to-day activities of all quality assurance personnel, ensuring efficiency and effectiveness of all on-site quality system activities.
- Provide quality
