- Legend Biotech USA, Inc. (Raritan, NJ)
- …aseptic manufacturing facility, preferably within quality control, quality assurance , training/systems applications, quality systems, or learning management ... systems.Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.Knowledge of Good Tissue Practices is required.Experience with training methodology, adult learning theory, and train-the-trainer… more
- Bayer (Othello, WA)
- …and adherence to Bayer’s Health, Safety, Environment (HSE) and Quality Assurance /Quality Control (QA/QC) standards (eg, general shop floor/machine safety and ... operating procedures;)Comply with internal procedures and support compliance with legal requirements applicable to area activities;Participate and prepare to lead Daily Direction Setting (DDS) meetings as needed; articulating shift objectives and allocating… more
- Boeing (Everett, WA)
- …will lead high‑visibility safety risk assessments, scale SMS performance, implement Safety Assurance , and serve as a key interface across assigned Airplane Programs ... assessment methods across teams. Oversee implementation and monitoring of Safety Assurance (SA) activities; coordinate with BCA teams to ensure timely identification… more
- Aequor (Irvine, CA)
- …process simplicity, clarity, repeatability, and robustness Provides on-going oversight and assurance that production equipment is properly maintained, safe, and in a ... state of control at all times Serves as a subject matter expert at specific product development phases for DFM, process development, and capability assessment reviews. Must have: Bachelor of Science in Optical, Opto-Mechanical, or Photonics Engineering or… more
- Cipla (Hauppauge, NY)
- …of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing ... and packing. Other duties [additional support] that management may assign from time to time. Perform AQL, Blend sampling, In-process Sampling, and inspections as required. Skills: Knowledge of Good Manufacturing Practices and Good Documentation Practices.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance knowledge including ... knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and… more
- AUROBINDO (Durham, NC)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several ... formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewEngineering /Manufacturing Operator is to perform all required Batch… more
- Cipla (Fall River, MA)
- …and CAPAs (Corrective and Preventive Actions). Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures (SOPs). Assist ... in coordinating materials, equipment, and workforce allocation for optimal resource utilization. Identify areas for operational improvements, focusing on reducing waste and enhancing efficiency. Assist in implementing new technologies and automation in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, technical operations or cell ... therapy.Experience with quality support in clinical manufacture is preferred.Flexible to work on weekends, as needed.Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy.GxP Quality System ... knowledge, including relevant regulations and guidances (eg 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems.Strong written and verbal communication skills, and analytical problem solving and… more
