Quality Investigator - Cell Therapy Manufacturing
BioPharma Consulting JAD Group
Quality Assurance InvestigatorGrow your quality career in cell therapy at a leading biotechnology company in Boston, Massachusetts. You will investigate manufacturing and QC deviations, find root cause and drive CAPAs to closure.What you'll do:Investigate standard-complexity deviations with interviews, GEMBA and root cause analysis tools.Propose CAPAs with SMEs; manage records in eQMS and meet due dates.Support change controls and effectiveness checks.Track deliverables and escalate risks to the team lead.Qualifications:Bachelor's degree in Engineering or related + 2–5 years.Pharma/biotech quality, manufacturing or engineering experience.Deviation/CAPA experience and eQMS.Clear technical writing.Contract: 12 months, with possible extensionShift: On-site; shift set by the hiring manager (may be non-standard)Start: Immediate
- ...The Manufacturing Technical Operations (MTO) Quality Investigations Specialist is responsible for the end‑to‑end execution of quality records supporting cell therapy manufacturing at the Boston site. This role focuses heavily on investigations , including Deviations,...QualityContract workShift work
$98.5k - $109.1k
...and complex principles and practices of cell processing and experience as an auditor... ...responsible assisting in the monitoring for quality to ensure that systems are appropriate,... ...infusional toxicities data Review manufacturing and quality control records. Document deviations...QualityFull timeFlexible hoursShift workWeekend work- ...Manufacturing Lead InvestigatorA Few Words About Us Integrated Resources... ...on delivering only the best quality talent, the first time and... ...Clinical Research, Rehabilitation Therapy and Nursing.Job... ...Under general supervision the Investigator will lead and manage evaluations...QualityWork at officeShift work
- ...Scorpion Therapeutics in the Boston area seeks a Senior Director of Quality Operations to oversee quality for clinical and commercial cell and gene therapy products, with responsibility for external manufacturing oversight. You will shape quality strategy and ensure GMP...Quality
$244.8k - $367.2k
...responsible for defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating model, and... ...capabilities across internal manufacturing sites and external partner... ...and health authority requests from investigational medicine to market authorization...QualityFull timeSummer workFlexible hours- ...Description Senior Director, CGT Quality Systems, Personalized... ...personalized medicine and advanced cell therapies across the patient journey.... ...with Global Quality and Manufacturing, MS&T, Regulatory,... ...and scalability across CGT investigations, change controls, risk assessments...Quality
- ...provides support for projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change... ...owner where applicable.Lead investigations and provide troubleshooting for... ...working with mammalian cell cultureExperience working in...QualityWork at officeWeekend workAfternoon shift
$111k - $123k
...generation of gene editing therapies to patients. The Company is... ...different tissues, organs and cell types. Prime Medicine is currently... ...a diversified portfolio of investigational therapeutic programs... ..., please visit .Department: Quality AssuranceReports to: VP, Quality...QualityFull timeTemporary workRemote work$153.9k - $230.9k
...Associate Director – Shift Quality Operations is an advanced technical... ...and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing. This role is... ...execution, deviation management, investigations, line clearance, contamination...QualityFlexible hoursShift work$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development... ...GMP activitiesOversee the QA support of Change Controls, GMP investigations and associated CAPAs.Track performance metrics and report to...QualityFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...company in Boston, Massachusetts. You will provide QA oversight of commissioning, qualification and validation for a cGMP cell and gene therapy manufacturing facility and its QC laboratories. What you'll do Provide QA oversight of CQV, periodic review and...Contract workImmediate startMonday to FridayShift work
$100k - $115k
...Description The field of gene therapy is growing rapidly and... ...vectors, and provide cell transduction for gene... ...biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions... ...Assist in deviation investigations, CAPA and Change Control...QualityLive inVisa sponsorshipShift work- ...Services is a leading insurance claims investigation and medical management company, specializing... ...vehicle by tracking and capturing high-quality video evidence of surveillance targets.... .... Technology: A reliable laptop, cell phone, and internet service are needed for...QualityLocal areaNight shiftWeekend work
- ...Services is a leading insurance claims investigation and medical management company, specializing... ...vehicle by tracking and capturing high-quality video evidence of surveillance targets.... .... Technology: A reliable laptop, cell phone, and internet service are needed for...QualityFull timeLocal areaNight shiftWeekend work
$244.8k - $367.2k
...executive leader responsible for defining and executing Cell & Gene Therapy quality vision, operating model, and organizational strategy at Vertex... ...scalable capabilities across internal and external manufacturing networks. Responsibilities Define and execute long-...Quality$156.6k - $234.8k
...Director overseeing GMP operational quality for cell and genetic therapies at a rare disease-focused... ...developing personnel while supporting manufacturing operations. Responsibilities... ...performing teams ~ Experience leading investigations, root cause analysis, and CAPA...QualityWork experience placement- ...experiments that advance our in vivo CAR-T programs, generate high-quality data, and develop skills in experimental design and analysis... ...The role suits an early-career scientist with hands-on mammalian cell culture and flow cytometry experience, meticulous records, and a...Quality
- ...The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory... ...successfully leading event investigations, Root Cause Analysis and... ...applications. Some experience with, Cell and/or Gene Therapy QA experience, working...QualityWork at office
- ...Sergeant, the Detective will perform comprehensive criminal investigations, non-criminal investigations, law enforcement and crime prevention... ...revision of policies and procedures, goals and objectives, quality assurance and risk management programs as requested by the...QualityFull timeFixed term contractLocal areaFlexible hours
- ...Affirmative Civil Enforcement (ACE) Investigator Employment Type: Full-Time, Experienced CGS is seeking an experienced ACE Investigator... ...demonstrating a commitment to honesty, professionalism, and quality work. Here at CGS we value honesty through hard work and...QualityFull timeWork at officeLocal areaRemote workFlexible hours
- ...Pharmaceuticals LLC in Boston is seeking a 2nd shift staff member for MTO to own and execute quality records including deviations, CAPAs, Change Controls, and Investigations across cell manufacturing. This on-site role emphasizes QA-aligned best practices, data review, interviews,...QualityShift workAfternoon shift
$80k - $400k
...Shared decision-making Section Faculty 16 M.D. and Ph.D. investigators who conduct research, pursue external funding, and mentor... ...researchers, and advanced practitioners dedicated to providing quality and excellence in teaching, research, and clinical care. To learn...QualityFull timeWork experience placementLocal areaWork from home- ...The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory... ...successfully leading event investigations, Root Cause Analysis and... ...applications. Some experience with, Cell and/or Gene Therapy QA experience, working...QualityWork at office
$100k - $115k
...SpecialistLexington, MAIn support of biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day... ...operations and vial visual inspections.Assist in deviation investigations, CAPA and Change Control implementations.Provide...QualityVisa sponsorshipShift work- ...Role Support Vertex Cell and Genetic Therapies by managing site scheduling processes and maintaining manufacturing schedule alignment. Responsibilities coordinate across schedulers... ...RTMS support, system updates, data quality, and issue escalation; manage scheduling...QualityFor contractors
$340k - $360k
...to developing transformative therapies for patients with serious unmet... ...are seeking a seasoned VP of Quality Assurance to lead and own our... ...ensure that all development, manufacturing, and clinical activities are... ...including biologics, and/or cell and gene therapies Prior experience...QualityWork at officeWork from homeFlexible hours- ...Job Description: The Quality Engineering and Validation... ...Drug Product manufacture. This position reports... ...Director GMP Quality - Cell & Gene. This is an onsite... ...Vertex Cell and Gene Therapy operations and capital... ...risk assessments, GMP investigations and CAPAs. Responsible...QualityWork experience placementRemote workMonday to Friday
$171.2k - $256.8k
...lethality to discover and develop therapies that take aim at critical... ...to the ability of cancer cells to evade immune cell killing... ...to the Executive Director, Quality, is responsible for leading... ...serious breaches, deviations)Lead investigations, root cause analysis, and...QualityContract work- ...Job Description The Associate Director, Quality Systems leads the strategy, design and... ...System supporting Artis BioSolutions' cell therapy, viral vector and fill-finish operations... ...working in a GMP biotechnology manufacturing environment, ideally with hands-on experience...QualityWork at officeMonday to Friday3 days per week
$185k - $225k
...delivery and internal manufacturing capabilities. Beam’s suite... ...Associate Director, Quality Control to lead the... ...deviations, laboratory investigations, change controls, CAPAs... ..., Molecular Biology, Cell Biology, Analytical Sciences... ...biologics, cell therapy, gene therapy, mRNA, or...QualityFull time
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