WuXi Biologics
Associate Director, Cranbury Quality Assurance
WuXi Biologics, Cranbury, New Jersey, United States
Associate Director, Cranbury Quality Assurance
Job Title
- Associate Director, Cranbury Quality Assurance Work Location
– Cranbury, NJ
WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. We have built an extraordinary team motivated by our culture of Passion, Reward, Opportunity, Unity and Determination. Responsibilities
Lead a team to support quality activities in MFG18 and DP12 to ensure all production activities are in compliance with current regulatory requirements, cGMP, and company SOPs. Responsible for review and approval manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, QRM, etc. QA responsible for quality events handling which happened in MFG18 and DP12 QA responsible for on-site quality monitoring of DS/DP, manufacturing, and participant in GMP production activities, such as process transfers, validation, etc. QA responsible for routine audit for manufacturing area, to ensure GMP production in compliance with all regulatory market, EU, FDA, and company standards. Ensure all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes are validated/qualified, operate as per design and are maintained in compliance with Cgmp, industry standards, and regulatory expectations. Ensure all system related Data Integrity activities e.g., system audit trail review, review of user profile and access, all laboratory testing data and related records, including but not limited, assay documentation, instrument cleaning and maintenance records are carried out according to WuXi Quality standards and GMP regulation. Collate and review data to be used in reports, investigations, key performance indicators, and other quality matrices. Other quality activities may be assigned as required. Qualifications
Bachelor’s degree or higher in Biopharma, biochemistry, chemical engineering, and related life science Minimum of 10 years’ experience working in a biologics or similar GMP environment as part of a quality assurance, quality control, technical services or manufacturing operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Strong experience in a Quality Engineering/Quality Assurance/Quality Validations Role for Biologics or related pharmaceutical/medical device manufacturing in an FDA/EU regulated environment Experience and exposure with liaising and responding to regulatory inspectors/client auditors. Strong technical aptitude is required. Previous experience managing a Quality Management System Experience with GMP processes like good documentation practice, change control, non-conformance management, corrective and preventative actions and SOP writing. Experience in training management, execution, and documentation Demonstrated understanding of principles of Good Manufacturing and Good Documentation practice. Strong knowledge of GxP regulations (e.g., FDA, EU-GMP Guideline) Compensation and Benefits The anticipated pay range for this position is $123k-209k.
WuXi Biologics is 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 disability
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Job Title
- Associate Director, Cranbury Quality Assurance Work Location
– Cranbury, NJ
WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. We have built an extraordinary team motivated by our culture of Passion, Reward, Opportunity, Unity and Determination. Responsibilities
Lead a team to support quality activities in MFG18 and DP12 to ensure all production activities are in compliance with current regulatory requirements, cGMP, and company SOPs. Responsible for review and approval manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, QRM, etc. QA responsible for quality events handling which happened in MFG18 and DP12 QA responsible for on-site quality monitoring of DS/DP, manufacturing, and participant in GMP production activities, such as process transfers, validation, etc. QA responsible for routine audit for manufacturing area, to ensure GMP production in compliance with all regulatory market, EU, FDA, and company standards. Ensure all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes are validated/qualified, operate as per design and are maintained in compliance with Cgmp, industry standards, and regulatory expectations. Ensure all system related Data Integrity activities e.g., system audit trail review, review of user profile and access, all laboratory testing data and related records, including but not limited, assay documentation, instrument cleaning and maintenance records are carried out according to WuXi Quality standards and GMP regulation. Collate and review data to be used in reports, investigations, key performance indicators, and other quality matrices. Other quality activities may be assigned as required. Qualifications
Bachelor’s degree or higher in Biopharma, biochemistry, chemical engineering, and related life science Minimum of 10 years’ experience working in a biologics or similar GMP environment as part of a quality assurance, quality control, technical services or manufacturing operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Strong experience in a Quality Engineering/Quality Assurance/Quality Validations Role for Biologics or related pharmaceutical/medical device manufacturing in an FDA/EU regulated environment Experience and exposure with liaising and responding to regulatory inspectors/client auditors. Strong technical aptitude is required. Previous experience managing a Quality Management System Experience with GMP processes like good documentation practice, change control, non-conformance management, corrective and preventative actions and SOP writing. Experience in training management, execution, and documentation Demonstrated understanding of principles of Good Manufacturing and Good Documentation practice. Strong knowledge of GxP regulations (e.g., FDA, EU-GMP Guideline) Compensation and Benefits The anticipated pay range for this position is $123k-209k.
WuXi Biologics is 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 disability
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