What are the responsibilities and job description for the Quality Assurance Specialist position at Evergreen Theragnostics?
About Evergreen
Evergreen Theragnostics, Inc. is a radiopharmaceutical company scaling up operations in Springfield, NJ. The state-of-the-art facility will provide contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
Job Description
The QA Specialist shall assist in the management and implementation of the Quality Management System (QMS). The QA specialist shall perform daily, weekly, monthly, and yearly QA activities such as internal and external audits, environmental monitoring, etc. The QA specialist shall also oversee inspection and testing of incoming and outgoing products to confirm quality conformance to prescribed regulatory and customer specifications. The QA Specialist shall analyze, investigate, trend quality events and report findings to upper management. QA Specialists shall also assist in the development and implementation of GMP documentations, such as SOPs, batch records, etc.
Education & Qualifications
• Bachelor’s Degree in a scientific field
• 2-3 years of experience in the pharmaceutical industry. Radiopharmaceutical experience preferred.
• Understanding of FDA, and other applicable regulatory requirements for finished pharmaceuticals
• Strong technical writing and oral communication abilities
• Experience working with electronic quality management and laboratory information management systems
• Ability to work with computers and software applications, such as Microsoft Office
• Ability to work in a small team setting and take on significant responsibilities during daily operations, early on in role
Responsibilities
• Plan, execute, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables.
• Responsible for disposition of incoming production materials and release activities for site manufactured drug products.
• Assist production and quality functions in tracking, documenting, and reporting quality levels as well as radiation, environmental and health and safety goals.
• Author documents and standard operating procedures, review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
• Perform internal and external quality audits and compile detailed reports of findings
• Monitor risk-management procedures and maintain logs to identify and report recurring issues to management and product development.
• Provide training and support to quality and production teams on systems, policies, procedures, and core processes.
• Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
• Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints.
• Support daily QA activities and other work-related duties as assigned.
