QA Specialist

Novogene is a leading global provider of genomic services and solutions. Leveraging the latest next-generation sequencing (NGS), bioinformatics expertise, and the largest sequencing capacity in the world, Novogene provides unsurpassed data quality and fast turnaround time to all our customers.

We are currently recruiting for a full time QA Specialist for laboratory sector. This role is highly collaborative and requires drive and excellent time management skills. You will work closely with different business sectors and deliver activities to support business success and compliance. The suitable candidate must work on-site.

Job Description:

1. Quality Management System/Environmental Management System Establishment and Management

a. Responsible for the introduction, implementation, and maintenance of quality management systems/environmental management systems (including but not limited to ISO17025, ISO14001, etc.).

b. Develop system-related documents and processes and organize internal training to ensure full understanding and execution of ISO standards/GCLP standards.

c. Collaborate with third-party certification bodies to ensure the company successfully passes quality management system/environmental management system certifications.

d. Establish and improve the company's quality management system to ensure compliance with industry standards and regulatory requirements.

e. Develop and update quality management processes and standards to ensure the high-quality delivery of the company's products and services.

f. Organize and coordinate internal quality audits to ensure that the quality management of various departments meets company requirements.

2. ESG (Environmental, Social, and Governance) Management

a. Collaborate with headquarters to develop and implement ESG policies for the German branch, ensuring corporate operations comply with relevant environmental, social, and governance regulations and standards.

b. Responsible for implementing and maintaining the environmental management system (e.g., ISO 14001), promoting green operations and sustainable development within the company.

c. Ensure continuous compliance with ISO 14001 environmental management system standards, guide the German branch through certification processes, monitor and evaluate environmental impacts, and propose continuous improvement measures to reduce waste and environmental risks.

d. Collaborate with headquarters to regularly provide ESG-related data for the German branch, showcasing its performance and achievements in environmental, social, and governance aspects to stakeholders.

3. Health and Safety Management

a. Develop and implement the company's health and safety policies to ensure the work environment complies with health and safety standards.

b. Attend Health and Safety training to obtain relevant qualifications, act as the Health and Safety officer, conduct health and safety risk assessments, develop preventive measures and emergency plans, and ensure employee health and safety.

c. Organize health and safety training to enhance employees' safety awareness and emergency response capabilities.

4. Management Review

a. Regularly organize management review meetings to assess the effectiveness and suitability of the quality management system.

b. Analyze management review results, propose improvement suggestions, and monitor the implementation of improvement measures.

c. Ensure that management is informed about the operation of the quality management system and its improvement needs.

5. Risk Assessment

a. Identify and assess potential risks in the quality management system and develop corresponding risk control measures.

b. Conduct regular risk assessments, update risk management plans, and ensure the effectiveness of risk control measures.

c. Organize risk management training to enhance employees' risk awareness and management capabilities.

6. Other Related Responsibilities

a. Coordinate and communicate with various departments to ensure the effective implementation of the quality management system/environmental management system company-wide.

b. Participate in new product development and project management, providing support and suggestions regarding quality management.

c. Monitor industry trends and regulatory changes to update the company's quality management system in a timely manner.

Criteria:

• Master's degree (MSc) or higher in a relevant scientific discipline.
• Hands-on experience with molecular laboratory techniques, including DNA/RNA extraction, PCR, and NGS platforms.
• Experience in writing and reviewing Standard Operating Procedures (SOPs) and clinical diagnostic reports adhering to national quality standards.
• Expertise in quality management systems, particularly ISO14001 standards
• Excellent verbal and written communication skills in English and German
• Ability to work both independently and as part of a multidisciplinary team.
• Experience in training and supervising staff.
• Understanding of health and safety regulations within a laboratory setting.
• Commitment to continuous professional development and staying updated with advancements in the field.

Novogene is an Equal Opportunity Employer that prohibits discrimination and harassment of any kind. Novogene is commited to ensure all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief, sex, sesual orientation, gender identity, national origin, disability, or any other legally-protected characterisitcs.

All employment decisions at Novogene are based on business requirements on its positions and skill sets on applicants. The business is committed to providing an inclusive and accessible recruiting experience for candidates with disabilities, or other physical or mental conditions.

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