- 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 in a QA role ... Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position requires… more
- Aequor (MA)
- …Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical ... materials for use in clinical trials. Ensure all requirements, stipulated in the CMO Quality Agreements, are being met. Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed. Participate in… more
- Aequor (Waltham, MA)
- …years of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working knowledge and ability to apply Quality ... and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use… more
- Aequor (West Greenwich, RI)
- …Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position requires ... working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and… more
- Novo Nordisk Inc. (Boulder, CO)
- …is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of ... Drug Product Manufacturing is accountable for clinical phase 1...patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management, Regulatory, Quality Control,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in support of ongoing laboratory investigations.Collaborate with Quality Assurance , Manufacturing, Technical Operations, Engineering and Maintenance to support ... a collaborative setting with quality counterparts that include quality Assurance , Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Oversee the efficient and timely release of patient-specific, finished drug product batches by collaborating with all functions (including Quality ... Assurance , Quality Control, Operations, Vein to Vein, Batch Advocate...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)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 of those within ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Aequor (Northborough, MA)
- …Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to US, ... Packaging interacts with and receives support from the Quality Assurance , Materials Management, Facilities Engineering, Validation, Metrology and Manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply ... working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or cell therapy. A minimum of 1 year of leadership experience… more
- Eisai, Inc (Raleigh, NC)
- …of global GxP and regulatory requirements related to the drug development process.Significant experience with manufacturing operations, biologics, and aseptic ... regulatory inspections. Able to handle a broad scope of quality assurance work, including reviewing documentation, communicating with individuals or larger groups,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and FDA/EU ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy.A minimum of a ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Tris Pharma (Monmouth Junction, NJ)
- …Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy.A minimum of 2 ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP regulations and Health ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma industry and ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy Knowledge of ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
