- Aequor (West Greenwich, RI)
- …for this role? IE office based, lab based, manufacturing floor? This is plant quality assurance role, therefore the EW will spend 50-60% of their time ... decision making.Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This… more
- Aequor (MA)
- …activities. Perform QA review of Executed Batch Records. Perform QA review of Quality Records, ie Deviations, CAPAs, OOS etc., as they occur. Perform QA review ... Provide SAP support for GMID and BOM approval. Provide Quality oversight and Quality guidance to resolve... guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug… more
- Aequor (Waltham, MA)
- …and/or 8&plus years of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working knowledge and ability to ... apply Quality principles and cGMPs in conformance to standards, preferably...related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug… more
- Aequor (West Greenwich, RI)
- …makings. Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This ... drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the Following: Provide … more
- Novo Nordisk Inc. (Boulder, CO)
- …disruptions to our patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management, Regulatory, ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or equivalent technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Project Management Specialist as part of the Quality team based… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience with drug -device combination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reasoning skills in support of ongoing laboratory investigations.Collaborate with Quality Assurance , Manufacturing, Technical Operations, Engineering and ... will be assigned, as necessaryKey Relationships:Work in a collaborative setting with quality counterparts that include quality Assurance , Manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …finished drug product batches by collaborating with all functions (including Quality Assurance , Quality Control, Operations, Vein to Vein, Batch ... 5 years of relevant work experience in Operations, Supply Chain, or Quality Assurance experience within a cGMP environmentFacilitate cross functional discussions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to 20/30 (Snellen) or betterWorks in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or cell therapy. A minimum… more
- Eisai, Inc (Raleigh, NC)
- …in regulatory inspections. Able to handle a broad scope of quality assurance work, including reviewing documentation, communicating with individuals ... Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.Audit and Compliance: Maintain audit readiness,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Aequor (Northborough, MA)
- …these functions, Packaging interacts with and receives support from the Quality Assurance , Materials Management, Facilities Engineering, Validation, Metrology ... Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to US,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Lead (1st or 2nd shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma ... and gene therapy manufacturing, including but not limited to deviations ( Quality Issues), investigations, CAPA management.Work cross functionally with SME's and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development… more
