Lonza
Quality Assurance Specialist III - Quality Assurance Support
Lonza, Houston, Texas, United States, 77246
Quality Assurance Specialist III - Quality Assurance Support
Lonza is hiring for the Quality Assurance Specialist III - Quality Assurance Support role in Houston, TX. The role interacts with Lonza’s suppliers and internal customers to obtain documentation required for material release, reviews internal and external material release documentation, and ensures timely release of raw material for production. The individual performs SAP transactions for material release and supports Quality functions within SAP. The role also manages part number processes, SAP master data review/approval, and material specification generations and/or approval. The position may involve owner or QA approver responsibilities for investigations or change controls and master document review. Overview
Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and the facility is growing. This role is part of the Quality Assurance group and requires a deeper understanding of cGMP documentation to support material release and related QA functions. Key Responsibilities
Interact directly with Lonza’s suppliers and internal customers to obtain documentation required for material release. Independent review and approve cGMP documentation (COA, internal and external test records, BSE/TSE statements, etc.) required for material release. Performs SAP transactions required for material release as well as other Quality functions within SAP. Supports part number process, SAP master data review and approval, and specification generations and/or approval. Acts as Supplier Qualification Point of Contact (SPoC) for the Lonza Houston site. Facilitates processing of vendor change notifications. Manages deviations and change controls as owner or QA approver in Trackwise system. Writes/revises master documents (e.g., forms, Standard Operating Procedures (SOPs), specifications). Maintains compliance with all required training and assists with training of fellow analysts. Key Requirements
Bachelor’s degree in life sciences, or related field. Advanced experience in the Quality Operations Field (3-6 years) GMP Commercial experience (3-6 years) Biopharmaceutical experience required (3-6 years) Experience with document reviews in any quality system. Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills. In-depth knowledge (Advanced) of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions. Proficient in the use of spreadsheets, databases, and word processing software. Prior experience with SAP, Trackwise, DMS, and LIMS are a plus. Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows. Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams. Leads by example and offers guidance to co-workers with respect to compliance and personal interactions. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, protected veteran status, or any other characteristic protected by law. Reference: R70586
#J-18808-Ljbffr
Lonza is hiring for the Quality Assurance Specialist III - Quality Assurance Support role in Houston, TX. The role interacts with Lonza’s suppliers and internal customers to obtain documentation required for material release, reviews internal and external material release documentation, and ensures timely release of raw material for production. The individual performs SAP transactions for material release and supports Quality functions within SAP. The role also manages part number processes, SAP master data review/approval, and material specification generations and/or approval. The position may involve owner or QA approver responsibilities for investigations or change controls and master document review. Overview
Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and the facility is growing. This role is part of the Quality Assurance group and requires a deeper understanding of cGMP documentation to support material release and related QA functions. Key Responsibilities
Interact directly with Lonza’s suppliers and internal customers to obtain documentation required for material release. Independent review and approve cGMP documentation (COA, internal and external test records, BSE/TSE statements, etc.) required for material release. Performs SAP transactions required for material release as well as other Quality functions within SAP. Supports part number process, SAP master data review and approval, and specification generations and/or approval. Acts as Supplier Qualification Point of Contact (SPoC) for the Lonza Houston site. Facilitates processing of vendor change notifications. Manages deviations and change controls as owner or QA approver in Trackwise system. Writes/revises master documents (e.g., forms, Standard Operating Procedures (SOPs), specifications). Maintains compliance with all required training and assists with training of fellow analysts. Key Requirements
Bachelor’s degree in life sciences, or related field. Advanced experience in the Quality Operations Field (3-6 years) GMP Commercial experience (3-6 years) Biopharmaceutical experience required (3-6 years) Experience with document reviews in any quality system. Prior experience with quality functions, aseptic techniques, GDP/GMP requirements, material release, investigation skills. In-depth knowledge (Advanced) of cGMP principles. Able to identify breach of cGMP principles and provide suggested corrective actions. Proficient in the use of spreadsheets, databases, and word processing software. Prior experience with SAP, Trackwise, DMS, and LIMS are a plus. Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows. Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams. Leads by example and offers guidance to co-workers with respect to compliance and personal interactions. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, protected veteran status, or any other characteristic protected by law. Reference: R70586
#J-18808-Ljbffr