Wuxi Apptec Philadelphia , PA 19107
Posted 5 days ago
Overview
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.
Our benefits include:
401K matching
PTO
Employee discount programs
Medical, dental and vision insurance
and much more
The Quality Assurance Manufacturing Specialist III is a senior role to plan and implement quality requirements, provide Quality oversight in manufacturing operations at the site, as needed and execute continuous improvements. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues to enable lot disposition or improvements for new and existing clients. Approves Certificate of Testing (CoT), Certificate of Analysis (CoA) and Certificate of Processing (COP) for manufactured batches in accordance with cGMP. Review and approves non-conformances, deviations, and CAPAs that are not batch-specific. Author and revise departmental SOPs to stay current with changes to GxP including FDA, EU and major regulatory bodies as well as guidance documents (i.e., ICH, ISPE, etc.)
Responsibilities
Reviews and approves Change Controls and Document Change Requests• Review and approves Non-Conformance Events and Deviations that are not batch-specific• Review and approves Label Specification Sheet (LSS) and Product Specification Sheet (PSS)• Review and approves executed Aseptic Processing Validation (APV) batch records• Review and approves APV summary reports• Approves COA's , COP's or COT's for executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner• Ensure QA checklist is adequate and comprehensive to enable batch disposition• Interacts with QA Manufacturing to provide quality perspective on routine operations and support systems. For example, through facility walk-through and/or output from Quality Management Review• Interacts with QA Manufacturing to communicate project requirements, and timeline to perform batch release• Writes, reviews and revises SOPs as required• Participates/Leads internal and client audits, and regulatory inspections• Participates/Leads internal facility walk-through in manufacturing areas and warehouses• Participates in quality and process improvement initiatives and project teams
Given authority to make decisions and sign documents relevant to batches manufactured in WuXi ATU. For example, bulk/finished product declaration.• Perform duties as assigned by QA Management
Qualifications
Knowledge / Skills / Abilities:
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin
Wuxi Apptec