Quality Assurance Specialist
1 month ago
Job Description - QA Specialist
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 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 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, CAPA implementation, yearly review, etc. The QA Specialist shall review, 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.
- 3-5 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.
- Experience working with cross-functional teams to meet project timelines
- Performing Root Cause Analysis and/or Quality Investigations, experience required (certification preferred).
- Ability to perform mathematical calculations and analysis from data generated through the Quality Control testing or manufacturing process.
- Have an SME-level understanding of cGMP and GDP requirements.
- Responsibilities
- Responsible for disposition of incoming production materials and release activities for site manufactured drug products.
- 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.
- 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.
- Maintain company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints.
- Identify and escalate non-conformances to site procedures, properly document and investigate Quality Events as per site SOPs and FDA guidance documents.
- Participate in and support both client and regulatory audits.
- Participate in CAPA teams, planning and implementation of continuous improvement initiatives
- Support daily QA activities such as document and batch record review when needed in addition to other work-related
- duties as assigned
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