What are the responsibilities and job description for the Quality Assurance Manager - OVERNIGHTS position at Evergreen Theragnostics?
Quality Assurance Manager – Overnight Shift (4 days)
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. The company expects rapid growth in the next few years.
Evergreen is a growing team, fostering a culture of collaboration and strong cross-functional communication to support end-to-end activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company into a cornerstone of the radiopharmaceutical industry. Partial equity-based compensation packages possible.
Job Responsibilities
- Oversee all day-to-day QA operations and related activities for the overnight shift.
- Manage a team of Quality Assurance professionals supporting routine batch release activities.
- Plan, execute, oversee inspection and testing of incoming and outgoing products to confirm quality conformance to specifications and quality deliverables.
- Responsible for disposition of incoming production materials and release activities for site manufactured drug products.
- Responsible for managing Quality Assurance Key Performance Indicators (KPIs) such as document review cycle times, and Quality Event cycle times.
- Author documents and standard operating procedures, review and approve 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 driving preventive action.
- Perform internal and external quality audits and compile detailed reports of findings.
- Develop and 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.
- Interact with CDMO clients to advise on protocol driven activities related to process development, update and validation related to QA requirements.
- Support daily QA activities and other work-related duties as assigned.
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