QC Analyst specializing in HPLC

Reports to:

Head of Quality Control

Primary Duties and Responsibilities:

Understanding the applicable regulatory guidelines, specifications, and standards.

Attend the training for a better understanding of testing procedures and company policies.

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 material, in-process material, finish product, and packaging material.

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.

Aware of regulatory requirements for analytical method validations.

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:

Above 5 years of experience in Biopharmaceutical R&D.

Technical skills:

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).

Comprehensive understanding of analytical testing, quality, and regulatory requirements in biologics manufacturing and controls.

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

Scinai is an equal-opportunity employer. Jobs are open to all qualified applicants, and we welcome people of diverse backgrounds and identities.

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