• Design, implement and optimize operational and quality policies and procedures, ensuring compliance with all applicable regulations (e.g. GLP, GCLP, CLIA, etc.), guidance, and standards, while ensuring business processes are designed to maximize value for internal and external clients

• Collect and monitor performance metrics, including identification of trends that require preventive action and the steps necessary to improve performance

• Monitor daily work operations and provide direction and guidance to staff to achieve unit or project goals. Interact with internal and external clients, by meeting regularly, responding to requests and explaining procedures

• Verify accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.

• Serve as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews lab investigations or root cause analysis.

• Host client and regulatory inspections/audits, and participate in developing and tracking corrective actions.

• Provide training for department and/or laboratory staff where required.

Requirements:

• Education and Experience

o Bachelor's degree or equivalent and relevant formal academic / vocational qualification

o Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).

• Knowledge, Skills and Abilities

o A working knowledge of worldwide industry best practice, guidance, and regulations, including GLP, GCLP, CLIA, ICH, and appropriate regional regulations and guidelines

o Working knowledge of project based or internal GLP/GCLP audits and vendor audits

o Excellent oral and written communication skills

o Strong problem solving, risk assessment and impact analysis abilities

o Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements

o Ability to function independently within a minimally supervised environment with exceptional attention to detail required

o Ability to accomplish tasks on time and perform administrative functions

上班地址：浙江省杭州经济技术开发区白杨街道科技园路2号1幢504-506室