QA Specialist - Pharmaceutical or Radiopharmaceutical Experience Required
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company based in Springfield, NJ. We operate in a brand-new state-of-the-art facility, focusing on CDMO services and the commercialization of our portfolio of radiopharmaceutical products.
Evergreen is a small team where all team members support each other in various 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 are possible.
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.
Education and 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