Laboratory Quality Consultant

Pengiklan Anonim; Tangerang; On-site; IDR 120.000.000 - 150.000.000; Full time

Job summary

A precision oncology company is seeking a Quality Consultant to oversee laboratory quality management and ensure compliance with medical regulations. Ideal candidates will have a Bachelor's degree and at least 3 years of experience in quality assurance within regulated environments. Strong knowledge of ISO standards and proficiency in Microsoft Office are required. This role is based in Tangerang, Indonesia.

Qualifications

• 3+ years of experience in quality assurance or quality control.
• Experience in NGS, molecular biology, or ISO-standard environments preferred.
• Familiarity with local Indonesian regulations for medical laboratories preferred.

Responsibilities

• Coordinate with the Laboratory Manager.
• Build and maintain the laboratory quality management system.
• Ensure compliance with medical laboratory license regulations.

Skills

Quality management standards knowledge

ISO 15189

Detail-oriented

Communication skills

Microsoft Office proficiency

Education

Bachelor's degree in Molecular Biology or related field

Job description

1. Functionally coordinate with the Laboratory Manager.

2. Collaborates with colleagues from other departments in the operational management of the Indonesia company.

Main Responsibilities

1. Responsible for the construction of the laboratory quality management system, in compliance with the 15189 requirements for medical experiment management, prepare, review & submit all quality system documents required for laboratory license review. Complete the target by the end of December 2025.

2. Responsible for the application, current review, and obtain of medical laboratory licenses, ensuring that the laboratory can obtain a medical laboratory license by January 2026.

3. Responsible for training laboratory related technical personnel on the laboratory quality management system, ensuring that the quality system operates normally in the laboratory.

Qualifications

1. Prerequisites:

a) College diploma or Bachelor's degree or above in Molecular Biology, Medical Laboratory Science, Biotechnology, Pharmacy, or a related field.

b) 3+ years of experience in quality assurance or quality control within pharmaceutical, medical device, medical testing laboratories, or similar regulated environments. Outstanding fresh graduates may be considered.

c) Experience in NGS, molecular biology laboratories, or ISO-standard environments is preferred.

2. Competencies and Skills:

a) Proficient in international quality management standards such as ISO 15189, CAP, or ISO/IEC 17025, with a strong desire to drive laboratory accreditation.

b) Familiarity with local Indonesian regulations governing medical laboratories is preferred.

c) Proficient in Microsoft Office software (Word, Excel, PowerPoint).

d) Detail-oriented, organized, with good document writing and organizing skills.

e) Good communication skills and team spirit.

f) Ability to flexibly arrange time to participate in laboratory reviews and meetings as needed.

https://www.genetronhealth.com/en/

Genetron Health is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, continuous disease monitoring and care, as wells as biopharma development services. Genetron Health offers customized services and products. The ultimate goal is to defeat cancer.

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