QC Analyst specializing in HPLC, Jerusalem Site

Reports to:

Head of Quality Control

Scinai BioServices supports biopharma innovators from early research to late-phase clinical production, delivering agile, cost-effective, and science-driven CDMO solutions backed by over 20 years of experience and a state-of-the-art cGMP facility.
Our holistic, partnership-focused approach ensures process excellence, accelerated timelines, and value beyond the project, helping innovators bring their therapies to life with confidence.

Primary Duties and Responsibilities:

·   SOP preparation for the operation and calibration of instruments, sample collection, and testing methodology for various samples.

·   Handling of instruments like HPLC, Spectrophotometers, TOC, and ELISA reader.

·   Preparation and maintenance of standard solutions.

·   Testing of raw materials, in-process materials, finished products, and packaging materials.

·   Record testing results in accordance with data integrity (ALCOA+) policies.

·   Monitor and maintain instrument and process logbooks.

·   Initiating and conducting OOS investigations.

·   Maintain testing material (EM bank strains)/ chemical and equipment Stock Register.

·   Perform Environmental Monitoring and WFI testing.

·   Perform tests for protein analysis, such as SDS-PAGE/WB, Lowry, ELISA, and Kinetics.

·   Involvement in internal audits.

·   Track QC results and data regularly as per the relevant procedures.

Education:

Master's/ Bachelor’s degree in Chemistry or Biochemistry.

Experience:

At least 3–5 years of experience in Quality Control within a pharmaceutical, biotechnology, or regulated laboratory environment.

Technical skills:

·   Comprehensive understanding of regulatory requirements, analytical testing, method validation, data integrity principles, and quality systems within pharmaceutical and biopharmaceutical Quality Control laboratories.

·   Knowledge of OpenLab EZChrom software with proficiency in controlling HPLC instruments, acquiring data, performing data analysis and processing, generating reports, and ensuring data integrity (setting up sequences, integrating peaks, and managing data).

·   Basic understanding of Good Manufacturing Practices and Quality Management System, especially related to the Quality Unit.

·   Planning and organisational skills.

·   Communication and interpersonal skills, good written and verbal skills. Ability to communicate clearly and be able to put forth views both up and down the hierarchy.

·   Problem-solving skills.  Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

·    Candidate should be a good team player both inter- and intra-departmental. He/ she should walk the talk and thus help build a strong team of Quality Professionals.

·   Should have the ability to work transparently while working with tight timelines.

·    Attention to details and quality orientation- able to accurately check processes and outputs.

·    Computer literacy, specifically MS Office, is a must.

Languages (speaking, writing, and reading):

Hebrew, English at a professional level.

Please submit relevant CVs to Gal.ron@scinai.com