The Associate Quality Assurance Specialist Testing reviews Testing batch records in accordance with current Good Manufacturing Practices (cGMP).  Monitors processes for adherence to established procedures/regulatory compliance.  Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner. 

Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoA’s), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP consults with QA Management to resolve complex quality issues in a timely manner.

Investigate and review non-conforming laboratory analytical chemistry testing results to determine root cause and product impact using root cause analysis, DSC, HPLC/UPLC; Conduct analytical chemical testing and laboratory investigations of OOS/OOT results for compliance with FDA regulations; Review and troubleshoot technical issues associated with biological laboratory testing, including ELISA, PCR, and virus testing; Provide cGMP guidance to ensure all non-conformances are closed to meet defined product release dates using Master Control, LIMS, Blue Mountain RAM; Develop and track CAPA plans for quality assurance; Evaluate trends in investigations and CAPA to identify major areas of...

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   PLEASE NOTE:  This is a night shift role.  Schedule is Monday - Friday and hours from 6:00pm - 2:30am

Pharmaceutical Manufacturing: The EHS Specialist II will be responsible for supporting EHS compliance and risk management within the PHL Campus. The EHS specialist will monitor and improve processes to prevent and eliminate injury and illness to employees and assist the company to comply with safety laws.

Works closely with Quality Assurance Management, Quality Assurance Managers and support functions in providing direct oversight and leadership in the support of Late Phase and Commercial Manufacture of Cell Therapy Products according to current Good Manufacturing Practices (cGMPs).  Direct department employees, resources and programs to ensure compliance with all regulatory requirements; specifically Good Manufacturing Practice (cGMP), Code of ederal Regulations (CFR), EU Guide to Good Manufacturing Practice, International Conference on Harmonization (ICH), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Ensure compliance of critical functions for the site, monitor, trend and report on all...

Manages the QC Flow Cytometry operations and staff.  Demonstrates mastery of flow cytometry theory and practice on multiple platforms.  Experienced Manager that demonstrates leadership in a fast-paced industry setting and operates with minimal oversight and has a clear understanding of business and GMP regulatory demands.   Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of...

Responsible for duties associated with two or more Quality System processes, including: the administration, reporting and process creation / optimization / automation, while ensuring accordance with current good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP) and current Good Tissue Practices (cGTP). The processes comprising the Quality Systems include: Non- conformance / Investigations, CAPA, Change Control, Customer Audits, Supplier Audits, Training, and Supplier Qualification Program. Duties include effectively interacting with Testing, Manufacturing, Project Management and Quality Assurance personnel in order to deliver...

Responsible for directing all facilities functions to ensure operational business units are supplied with necessary physical property to meet company objectives including facility operation, maintenance and engineering. Specific responsibilities include preventative maintenance of facilities/systems, monitoring, coordination with metrology and validation, managing facilities change controls, troubleshooting equipment processes, supporting up-to-dates to as-built engineering drawings and Validation Master Plans, managing external contractors, writing reports and staffing and supervising a Facilities group competent in current Good Manufacturing Practices (cGMP) and cleanroom behavior. Interacts with internal departments as well as withbmaterial/equipment...

Responsible for supervising Quality Control activities within the production facility. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Has a strong working knowledge of the regulatory compliance requirements for the production of biologics used in clinical studies. Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues. Demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Participates in...

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role:  Sunday - Tuesday with alternating Wednesday: 2:00pm - 2:30am

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role:  Thursday - Saturday with alternating Wednesday from 2:00pm - 2:30am

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role: Thursday- Saturday with alternating Wednesday from 7:00am - 7:30pm

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role:  Thursday - Saturday with alternating Wednesday from 7:00am - 7:30pm

Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement.

Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement. 

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsible for coordinating the training for those who produce Master and Working Cell Banks and activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs)   Monday to Friday Standard Business 100% Onsite at our Philadelphia, PA location

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.   

Job Summary:   Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues or improvements for new and existing clients, including being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances, deviations, and CAPAs in accordance with cGMP. Prepare Certificate of Analysis for batch release.