QC Analyst

7 days ago


Tabarīya, Northern District, Israel Syqe Medical Full time ₪40,000 - ₪80,000 per year

Syqe Medical is a pioneering med-tech company developing innovative inhalation technologies for precise drug delivery. Our mission is to enhance patient care by leveraging breakthrough technology to improve treatment outcomes.

We are looking for a QC Analyst to join our Tiberias site. As a QC Analyst you will be performing analytical testing and routine lab activities to ensure product quality and regulatory compliance. The role also includes method validation, documentation, equipment maintenance, and support for audits and continuous improvement initiatives.

Position Summary

The Analytical Laboratory Analyst is responsible for performing routine laboratory activities in compliance with quality, safety, and regulatory standards. The role involves conducting analytical tests on raw materials, intermediates, and finished products; supporting method validation (including protocol preparation, study execution, data analysis, and report writing); and contributing to the development and revision of work instructions (WIs), standard operating procedures (SOPs), and analytical methods. In addition, the analyst participates in internal and external audits (e.g., FDA, GMP), by preparing relevant documentation, presenting analytical data, and addressing auditor inquiries in accordance with the company's quality system requirements.

Responsibilities
  • Work in accordance with GMP rules, quality standards, and laboratory safety procedures. Analyze and report test results with complete accuracy, traceability, and data integrity.
  • Perform routine analytical testing using laboratory instruments (UPLC, Mastersizer, KF, UV/VIS etc.) and other analytical equipment, following approved analytical methods and written procedures. Conduct inspection and evaluation of laboratory results, including raw materials, in-process control, finished products, stability and R&D samples.
  • Maintain analytical equipment, including routine calibration, troubleshooting, and preventive maintenance activities.
  • Participate in the validation of analytical methods, including protocol execution and documentation.
  • Identify, document, and participate in investigations of out-of-trend (OOT), out-of-specification (OOS), and deviation events. Assist the investigation of production-related deviations and non-conformities when required.
  • Collaborate in drafting, revising, and implementing WIs, SOPs, and analytical methods to promote accuracy, harmonization, and compliance with regulatory expectations.
  • Participate in internal and external audits, including preparation of laboratory documentation, presentation of analytical data, and response to auditor inquiries.
  • Perform QC review of laboratory data and documentation to confirm accuracy, data integrity, and compliance with GMP and internal quality procedures.
Requirements
  • Previous experience working in laboratory (at least 2 years).
  • Familiarity with laboratory equipment and instruments - HPLC, GC
  • Previous familiarity with GMP and ISO an advantage.
  • Relevant bachelor's degree (chemistry, chemical engineering, food, etc.)