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Quality Assurance Supervisor
2 months ago
WuXi AppTec is a leading global contract development and manufacturing organization (CDMO) dedicated to advancing the development and commercialization of cell and gene therapies. We are seeking a highly skilled Quality Assurance Supervisor to join our team.
Key Responsibilities:- Coordinate and oversee the day-to-day activities of the QA staff, including training and development.
- Monitor and maintain compliance with current regulatory requirements, including cGMP, GLP, GTP, CFR, PTC, and ICH.
- Drive continuous quality improvement through communication, training, waste reduction, and mistake-proofing.
- Lead and participate in cross-functional teams and projects, representing quality in a positive and compliant manner.
- Conduct documentation review and approval, including testing and manufacturing batch records, cleaning records, client protocols, training records, and qualification/validation documents.
- Support QA aspects of the change control process and ensure compliance.
- Support and participate in client and regulatory audits/inspections.
- High School Diploma or equivalent required.
- 5+ years of relevant technical experience, with at least 2 years in a lead/leadership/supervisory role.
- BS/BA in a science-related field preferred, or a combination of relevant experience and education.
- Proficient in oral and written communication skills, with the ability to read, write, and understand English.
- Proficient in Microsoft Office (Excel, Word, Outlook).
At WuXi AppTec, we value integrity and dedication, working together and sharing success, and doing the right thing and doing it right. We are committed to providing opportunities for internal growth and have a dedicated and accessible Human Resources team.
We provide equal employment opportunity to all individuals, regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.