Job detailsKelly Science is seeking an Overnight QA Specialist for a growing company located in Springfield, NJ.Shift: Wednesday-Sunday 9pm-8am (1 hour)Employment Type: Full Time; Direct HireJob Duties:
- 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
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.
Interested? Please apply today for immediate consideration!9579048