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Quality Assurance Specialist I
2 months ago
Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. The successful candidate will be responsible for ensuring the quality of our laboratory testing data and records, in accordance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies.
Key Responsibilities:
- Quality Assurance: Review laboratory testing data and records to ensure compliance with cGMP and GLP regulations.
- Process Monitoring: Monitor processes for adherence to established procedures and regulatory compliance.
- Guidance and Consultation: Provide guidance on quality-related issues and consult with QA Management to resolve complex quality issues.
- Regulatory Compliance: Stay current with changes to GXP, including FDA and EU regulations, and guidance documents.
- Communication: Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support systems.
- Documentation: Compile and review raw data, batch records, and test results, including Final Reports and COAs.
- Non-conforming Events: Review and approve Non-conforming Events (NCE), Deviations, and Laboratory Investigation Reports (LIR).
- SOPs and Document Control: Write and revise SOPs as necessary, and review and approve document change requests.
- Quality Inspections: Perform timely review of complex study files, such as Assay Validations, Qualifications, Viral Clearance, and QA inspections.
- Training and Development: Coordinate area training and participate in quality and process improvement initiatives.
Requirements:
- Education: Bachelor's degree in a Science-related field or equivalent experience.
- Experience: 4+ years of relevant experience or equivalent.
- Skills: Knowledge of GLP and cGMP requirements, PTC guidelines, and ISO17205; ability to use computer equipment and software (Microsoft Word, Excel, Outlook, and Access); ability to accurately and reproducibly perform arithmetic, algebraic, and geometric calculations; ability to record data accurately and legibly; ability to use judgment as dictated by the complexity of the situation; ability to understand and follow verbal or demonstrated instructions; ability to work effectively as part of a team and to exhibit effective interpersonal skills; ability to receive, comprehend, and to effectively communicate detailed information through verbal and written communication; proficiency in Oral & Written communication skills; ability to read, write, and understand English.
