Lab Quality Assurance II
Location: Zhongshan District, Taipei, Taiwan
Employment Type: Full-Time
Job ID: 3678
Industry: Clinical Research | Biotechnology | Central Laboratory | Quality Assurance
Posting Date: January 20, 2026
About the Company
Novotech is a global full-service Contract Research Organization (CRO) headquartered in Sydney, Australia, with operations across Asia-Pacific, North America, and Europe. With more than 3,000 employees, 34 offices, and over 5,000 site partnerships, Novotech delivers end-to-end clinical development services across all clinical trial phases and therapeutic areas. The organization operates under ISO 27001 and ISO 9001 certified quality management systems, ensuring the highest standards in data security, regulatory compliance, and laboratory quality.
Position Overview
Novotech is seeking an experienced Lab Quality Assurance II professional to support quality oversight and compliance within its Central Laboratory operations in Taiwan. This role is responsible for ensuring laboratory activities adhere to applicable CAP, GCP, GLP, and regulatory standards while supporting analytical operations, documentation control, computerized system compliance, and quality improvement initiatives. The position is well-suited for laboratory professionals with strong regulatory knowledge and hands-on quality assurance experience in clinical or regulated laboratory environments.
Key Responsibilities
Perform laboratory and quality-related activities in accordance with approved SOPs, protocols, and regulatory guidance.
Draft, review, and approve quality and technical documentation including SOPs, protocols, analytical results, validation records, reports, and test methods.
Support laboratory logistics and operational quality activities including procurement, inventory control, and administrative processes.
Oversee instrument maintenance, calibration coordination, and laboratory workspace compliance.
Act as system owner for assigned computerized systems, including validation testing, periodic system reviews, and compliance documentation.
Participate in CAP, GCP, GLP, and regulatory training programs and support audit readiness activities.
Support sample collection kit preparation, labeling processes, and analytical study quality oversight.
Contribute to analytical study project management and GLP study responsibilities as assigned.
Provide additional quality or laboratory support as delegated by the line manager.
Required Qualifications
Education:
Bachelor of Science (4-year degree) in Biochemistry, Biotechnology, Chemistry, Laboratory Science, or a related discipline.
Advanced degree preferred for Associate Researcher or Senior Researcher roles.
Experience:
Minimum 3 years of laboratory or quality assurance experience in a regulated clinical or laboratory environment preferred.
Well-qualified junior candidates with relevant laboratory exposure may be considered.
Licensure & Certification:
Medical Technician License required for Associate Researcher or Senior Researcher roles within Central Laboratory functions.
Knowledge, Skills, and Competencies
Strong familiarity with laboratory operations, quality systems, and compliance processes.
Excellent working knowledge of CAP, GCP, GLP, applicable local regulations, and international regulatory requirements.
Experience with documentation control, audit readiness, and computerized system validation.
Strong verbal and written English communication skills; additional language proficiency is an advantage.
Demonstrated problem-solving, time management, and prioritization abilities.
Ability to work independently and collaboratively in a cross-functional, regulated environment.
Why Join Novotech
Novotech offers an inclusive, collaborative, and growth-focused workplace. Employees benefit from flexible working arrangements, paid parental leave, wellness initiatives, continuous learning opportunities, and strong leadership support. The organization is committed to diversity, equity, and inclusion and actively encourages applications from individuals of all backgrounds, including those identifying as LGBTIQ+, individuals with disabilities, and those with caring responsibilities.
As a Circle Back Initiative Employer, Novotech is committed to responding to every application.
Application Process
Interested candidates are encouraged to apply with an updated CV highlighting laboratory quality assurance experience, regulatory expertise, and compliance achievements. Applications are reviewed on a rolling basis.
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