Quality Manager

Quality Manager

Job Responsibilities:

1.Lead and coordinate internal and external audits of quality systems such as CAP and ISO15189. Be responsible for establishing, implementing, supervising, and maintaining the company's quality management system (covering all aspects including personnel, equipment, materials, methods, andenvironment).

2. Be responsible for investigating, handling, and reporting quality incidents.

3.Be responsible for monitoring the production process, analyzing and handling quality anomalies, and authorizing the release of products that meet quality standards. Ensure strict compliance with all documents related to production and quality management.

4.Be responsible for organizing regular self-inspections, conducting comprehensive laboratory inspections in accordance with regulations and documents, and ensuring that self-inspection reports meet the required content.

5.Be responsible for organizing and implementing internal and external audit activities, and tracking the improvement and implementation of non-conformities identified during internal and external audits.

6.Complete other tasks assigned by superiors as required.

1.Bachelor's degree or above in biology, chemistry, pharmacy, laboratory science, or other related fields.

2.Over 3 years of quality management experience in a biological or related industry, with familiarity in quality management systems such as CAP and ISO15189. Possessing CAP/ISO15189 internal auditor qualifications is preferred.

3.Strong leadership, analytical, and problem-solving skills. Excellent external communication, expression, and coordination abilities. Ability to handle multiple tasks under pressure and to communicate and coordinate effectively with various departments and team members to ensure the implementation of all tasks.

4.Familiarity with molecular biology, NGS (Next-Generation Sequencing), and second-generation sequencing will be given priority.

5.Strong execution ability and certain analytical, summarizing, and reporting skills.

6.Work with rigor, diligence, proactivity, and a strong sense of responsibility.

7.Proficiency in written and spoken English is preferred.

Job Responsibilities:

1. Lead and coordinate CAP, ISO15189 and other quality systems internal and external audits, responsible for establishing, implementing, supervising and maintaining the company's quality management system (involving people, machines, materials, methods, environment and other aspects) ;

2. Responsible for quality accident investigation, handling and reporting;

4. Responsible for organizing regular self-inspection, conducting a comprehensive inspection of the laboratory according to regulations and documents, and ensuring that the self-inspection report meets the required content;

5. Responsible for organizing and implementing internal and external audits, and following up on the improvement and implementation of internal and external audit findings.

6. Complete other work tasks assigned by your supervisor as required.

Requirements:

1. Biology, chemistry, pharmacy, testing or other related fields, bachelor's degree or above;

2. Have more than 3 years of quality management experience in biotech companies,Familiar with CAP, ISO15189, etc. quality management systems, with CAP/ISO15189 internal auditor qualifications preferred ;

3. Have strong leadership, analysis, and problem-solving skills, good external communication and expression skills and coordination skills, and a certain stress resistance ability when facing multiple tasks, and be able to communicate and coordinate with various departments/members in a timely manner to implement each work;

4. Familiar with molecular biology, NGS, second-generation sequencing is preferred;

5. Have strong execution ability; some analysis, summary, and reporting skills;

6. Work rigorously, responsibly, and proactively, with a strong sense of responsibility.

7. Applicants with English writing and speaking skills are preferred.