Job Title:

Senior QA Specialist I Reports to:

Quality Assurance Manager Location:

US-CRAN Job Summary:

We're seeking an experienced QA Senior Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA training, facilitating the training methods, and should have great knowledge of training skills, ensuring quality and timely delivery. Coordinate cross-functional teams, manage timelines, and ensure GMP compliance. Drive training coordinators successfully through effective communication and Training risk management.

Key Responsibilities:

• Oversee QA training related projects, ensuring timely completion and quality
• Coordinate cross-functional teams (QC, Regulatory and other relevant departments etc.)
• Develop and execute project plans, timelines related to training
• Ensure compliance with GMP, regulatory requirements
• Identify and mitigate project risks, track progress Support audits and other activities as required.

Requirements :

• Bachelor's/Master's in relevant field (e.g., Life Sciences, Pharmacy)
• 3-5 years in QA training or learning and development, preferably in pharma/biotech
• GMP regulations, project management methodologies
• Strong communication, problem-solving, and organizational skills and Tools such Master control, Veva, Up4growth, Compliance Wire, Trackwise or any training related tools.

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability