Quality Assurance Manufacturing Specialist III - Batch Release - WuXi AppTec
Philadelphia, PA
About the Job
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
• 10+ years of relevant experience in the biopharmaceutical industry
• Bachelors’ degree in a Science related field
Knowledge / Skills / Abilities:
• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• Perform well in defined procedures and show progress to independent performance of tasks
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Displays good level of problem solving ability and offer suggestions to supervisor on complex issues
• Sound knowledge and interpretation of FDA and EU cGMP requirements
• Extensive experience in writing and/or reviewing/approving Investigations / Deviations / CAPA’s preferable
• Ability to work effectively as part of a team and exhibit excellent interpersonal skills.
• Ability to make sound decisions about scheduling, allocation of resources and managing competing priorities
• Flexible in managing deliverables and work hours to meet business objectives.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
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
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Job Locations _US-PA-Philadelphia_
Job ID _2024-13235_
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
• 10+ years of relevant experience in the biopharmaceutical industry
• Bachelors’ degree in a Science related field
Knowledge / Skills / Abilities:
• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• Perform well in defined procedures and show progress to independent performance of tasks
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Displays good level of problem solving ability and offer suggestions to supervisor on complex issues
• Sound knowledge and interpretation of FDA and EU cGMP requirements
• Extensive experience in writing and/or reviewing/approving Investigations / Deviations / CAPA’s preferable
• Ability to work effectively as part of a team and exhibit excellent interpersonal skills.
• Ability to make sound decisions about scheduling, allocation of resources and managing competing priorities
• Flexible in managing deliverables and work hours to meet business objectives.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
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
Need help finding the right job?
We can recommend jobs specifically for you!
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)
Job Locations _US-PA-Philadelphia_
Job ID _2024-13235_
Source : WuXi AppTec
