Quality Assurance Manager Overnight Shift
2 months ago
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, providing contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We have recently submitted our first New Drug Application (NDA) to the US FDA.
We also operate our own cutting edge cancer research laboratories, developing proprietary, radiotherapeutic medicines. 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 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.
Qualifications/Skills:
- Bachelor’s Degree in a scientific field
- 5-8 years of experience in the pharmaceutical industry required. Previous supervisor/management experience preferred.
- Batch disposition/batch release 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
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