{"schemaVersion":"jobsearcher.job.v1","id":"bcdb2669cf22c8087f8f8d2c","url":"https://jobsearcher.com/jobs/bcdb2669cf22c8087f8f8d2c","canonicalUrl":"https://jobsearcher.com/jobs/bcdb2669cf22c8087f8f8d2c","title":"QA Specialist","description":"1. PURPOSE AND SCOPE OF POSITION:\nThe Principal Specialist is responsible for supporting Warren Cell Therapy Quality Risk Management Program and providing quality oversight for Site Technology Transfer activities and Validation activities in accordance with BMS policies, standards, procedures and Global cGMP in a fast-paced, highly collaborative clinical manufacturing facility producing cell therapy CAR T and engineered T Cell products for first-in-human and early phase trials. Functional responsibilities for the incumbent include facilitating risk assessments to identify risk areas and risk mitigation measures, ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities; ensuring accurate and timely review of technology transfer documents; ensuring accurate and timely review of investigations and evaluation of change controls.\n2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities\nMust have GMP, Quality, and in-depth risk management knowledge.\nMust be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.\nMust manage development of technical or scientific initiatives and activities by interdisciplinary teams.\nMust have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.\nMust be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.\nRequires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.\nMust provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.\nRoutinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.\nAble to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.\nEffectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.\nMust be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.\nConsults management for advice on complex issues.\nWork is self-directed.\nIs recognized Subject Matter Expert within the group.\nAble to prepare written communications and communicate problems to management with clarity and accuracy.\nHas advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.\nUnderstands fundamental scientific problems.\nAble to write and review reports with clarity and brevity.\nAble to produce data reports with precision.\n3. DUTIES AND RESPONSIBILITIES\nSupports all activities for the QA Engineering group.\nSupport cross functional departments on risk identification, root cause analysis and investigative measures and support evaluation and implementation of a plan to mitigate process and/or product risks\nContribute to the writing, coordination, review, approval and maintenance of the Warren Risk Management Standard Operating Procedures (SOPs) and associated documentation.\nDevelop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.\nDevelops and Maintains Quality Metrics to monitor compliance\nEvaluate and report key performance metrics, analyze data and lead improvement initiatives.\nSupport risk owners in planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.\nOccasionally, facilitate complex or highly cross-functional risk assessments\nEnsure product risk management documentation/files are maintained, with good documentation practices and in compliance with Warren Quality System.\nPartner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.\nDrive continuous improvement for effective risk management and to address recurring issues identified throughout Warren.\nTrack and verify appropriate corrective actions have been implemented, documented and align with source event.\nMaintain Warren Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.\nAssist the risk owner to schedule and facilitate Warren risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.\nConduct risk reviews and escalate findings, as appropriate, to Manager and Warren Leadership with resolution and recommendations.\nRepresent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.\nWork independently and perform with a high degree of accuracy.\nApply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.\nProactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.\nProvide subject-matter expertise and consultation to risk assessment teams at the site. Develop and deliver training on QRM concepts, methods and regulatory expectations.\nCollaborates with stakeholders to develop appropriate actions to resolve quality system issues\nAct as primary link to other CTDO sites to ensure Quality systems are properly implemented and consistent\nSupport the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.\nAssures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.\nEnsure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.\nReview media simulation activities to ensure successful execution and documentation.\nEnsure site is compliant with global and regulatory data governance and data integrity requirements.\nEstablishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.\nWork with laboratory management to ensure laboratory activities comply with global regulatory requirements.\nEnsure procedures are adequate to review and confirm appropriateness of laboratory raw data.\nReview/approval of technology transfer related deviations/discrepancies.\nEnsure the site stability program meets global and regulatory requirements.\nEnsure process and method transfers, method qualifications/verifications, and analyst trainings meet company and regulatory requirements.\n4. EDUCATION AND EXPERIENCE (As Applicable)\nB.S. degree required.\nMinimum of seven years of experience in the pharmaceutical or related industry.\nExperience in CAR T or Biologics preferred.\nProfessional certification in Quality Risk Management preferred.\nEquivalent combination of education and experience acceptable.\nJob Types: Contract, Full-time\nPay: $45.00 - $52.00 per hour\nSchedule:\n8 hour shift\nAbility to commute/relocate:\nTownship of Warren, NJ 07059: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nCAR T: 3 years (Required)\nQuality Risk Management: 3 years (Required)\nGMP: 3 years (Required)\nQuality issues: 3 years (Required)\nWork Location: In person","company":"Codetru","rawCompany":"codetru","city":"Hackettstown","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-08-06T11:16:10.379Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"QA Specialist","description":"1. PURPOSE AND SCOPE OF POSITION:\nThe Principal Specialist is responsible for supporting Warren Cell Therapy Quality Risk Management Program and providing quality oversight for Site Technology Transfer activities and Validation activities in accordance with BMS policies, standards, procedures and Global cGMP in a fast-paced, highly collaborative clinical manufacturing facility producing cell therapy CAR T and engineered T Cell products for first-in-human and early phase trials. Functional responsibilities for the incumbent include facilitating risk assessments to identify risk areas and risk mitigation measures, ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities; ensuring accurate and timely review of technology transfer documents; ensuring accurate and timely review of investigations and evaluation of change controls.\n2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities\nMust have GMP, Quality, and in-depth risk management knowledge.\nMust be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.\nMust manage development of technical or scientific initiatives and activities by interdisciplinary teams.\nMust have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.\nMust be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.\nRequires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.\nMust provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.\nRoutinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.\nAble to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.\nEffectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.\nMust be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.\nConsults management for advice on complex issues.\nWork is self-directed.\nIs recognized Subject Matter Expert within the group.\nAble to prepare written communications and communicate problems to management with clarity and accuracy.\nHas advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.\nUnderstands fundamental scientific problems.\nAble to write and review reports with clarity and brevity.\nAble to produce data reports with precision.\n3. DUTIES AND RESPONSIBILITIES\nSupports all activities for the QA Engineering group.\nSupport cross functional departments on risk identification, root cause analysis and investigative measures and support evaluation and implementation of a plan to mitigate process and/or product risks\nContribute to the writing, coordination, review, approval and maintenance of the Warren Risk Management Standard Operating Procedures (SOPs) and associated documentation.\nDevelop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.\nDevelops and Maintains Quality Metrics to monitor compliance\nEvaluate and report key performance metrics, analyze data and lead improvement initiatives.\nSupport risk owners in planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.\nOccasionally, facilitate complex or highly cross-functional risk assessments\nEnsure product risk management documentation/files are maintained, with good documentation practices and in compliance with Warren Quality System.\nPartner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.\nDrive continuous improvement for effective risk management and to address recurring issues identified throughout Warren.\nTrack and verify appropriate corrective actions have been implemented, documented and align with source event.\nMaintain Warren Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.\nAssist the risk owner to schedule and facilitate Warren risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.\nConduct risk reviews and escalate findings, as appropriate, to Manager and Warren Leadership with resolution and recommendations.\nRepresent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.\nWork independently and perform with a high degree of accuracy.\nApply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.\nProactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.\nProvide subject-matter expertise and consultation to risk assessment teams at the site. Develop and deliver training on QRM concepts, methods and regulatory expectations.\nCollaborates with stakeholders to develop appropriate actions to resolve quality system issues\nAct as primary link to other CTDO sites to ensure Quality systems are properly implemented and consistent\nSupport the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.\nAssures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.\nEnsure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.\nReview media simulation activities to ensure successful execution and documentation.\nEnsure site is compliant with global and regulatory data governance and data integrity requirements.\nEstablishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.\nWork with laboratory management to ensure laboratory activities comply with global regulatory requirements.\nEnsure procedures are adequate to review and confirm appropriateness of laboratory raw data.\nReview/approval of technology transfer related deviations/discrepancies.\nEnsure the site stability program meets global and regulatory requirements.\nEnsure process and method transfers, method qualifications/verifications, and analyst trainings meet company and regulatory requirements.\n4. EDUCATION AND EXPERIENCE (As Applicable)\nB.S. degree required.\nMinimum of seven years of experience in the pharmaceutical or related industry.\nExperience in CAR T or Biologics preferred.\nProfessional certification in Quality Risk Management preferred.\nEquivalent combination of education and experience acceptable.\nJob Types: Contract, Full-time\nPay: $45.00 - $52.00 per hour\nSchedule:\n8 hour shift\nAbility to commute/relocate:\nTownship of Warren, NJ 07059: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nCAR T: 3 years (Required)\nQuality Risk Management: 3 years (Required)\nGMP: 3 years (Required)\nQuality issues: 3 years (Required)\nWork Location: In person","datePosted":"2026-08-06T11:16:10.379Z","dateModified":"2026-08-06T11:16:10.379Z","hiringOrganization":{"@type":"Organization","name":"Codetru","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hackettstown","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bcdb2669cf22c8087f8f8d2c"},"url":"https://jobsearcher.com/jobs/bcdb2669cf22c8087f8f8d2c"}}