Senior QA Specialist
WuXi Biologics · Cranbury, NJ · 1 wk ago
Quality AssuranceFull-time
About the role
We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA projects, ensuring quality and timely delivery, coordinating cross-functional teams, managing timelines, and ensuring GMP compliance. Drive project success through effective communication and risk management.
Responsibilities
- Oversee QA projects, ensuring timely completion and quality
- Coordinate cross-functional teams (QC, Regulatory and other relevant departments, etc.)
- Develop and execute project plans and timelines
- Ensure compliance with GMP and regulatory requirements
- Identify and mitigate project risks, track progress
- Collaborate with stakeholders on project scope and changes
- Support audits and other activities as required
Requirements
- Bachelor's or Master's degree in a relevant field (e.g., Life Sciences, Pharmacy)
- 3–5 years of experience in QA or project management, preferably in pharma/biotech
- Knowledge of GMP regulations and project management methodologies
- Strong communication, problem-solving, and organizational skills
Skills
- Project management tools: Jira, Aspera, MS Project
- Document control tools: SharePoint, Document Vault