- Merck & Co. (Rahway, NJ)
- …Literacy, Data Analysis, FDA Regulations, Good Manufacturing Practices ( GMP ), Laboratory Techniques, Manufacturing Quality Control, Master Batch Records, ... is preferable. GMP : Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report… more
- Merck & Co. (Rahway, NJ)
- …is preferable. GMP : Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development… more
- ValSource, Inc. (Rahway, NJ)
- …validation and equipment qualification activities, and ensuring compliance with FDA , GMP , and other regulatory requirements. ResponsibilitiesOn-Site Project ... Regulatory Compliance: Ensure compliance with all relevant regulatory standards, including FDA , GMP , and ICH guidelines, during on-site validation. Prepare… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and ... direction for transitioning from clinical to commercial phase GMP operations.Partners with other internal and external Quality Heads to ensure harmonization and… more
- Cipla (Hauppauge, NY)
- …conducting quality inspections. The role also ensures adherence to GMP and GDP standards, handles non-conformance issues, supports supplier management, and ... floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality ...to time. Skills: Strong understanding of Good Manufacturing Practices ( GMP ), Good Distribution Practices (GDP), FDA and… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- … Operations in maintaining an effective Quality Assurance (QA) program, and GMP Quality Management System which consistently delivers high quality ... customer complaints. This person and their team assist in maintaining the companys GMP Quality Management System program. ESSENTIAL DUTIES: Operates under the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as ... seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head...across all functions and sites.Support the development of the GMP Compliance program related to clinical/ commercial stage and… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …System Validation (CSV) is a plus.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience ... a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Process...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in ... a QA Validation Specialist III as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Validation...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Cipla (Fall River, MA)
- …in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA , ). Maintain and ensure the proper documentation of all quality systems ... role and a member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal...the company remains compliant with all regulatory requirements (eg, FDA , ICH, EMA). Support risk assessments and help mitigate… more
- Cipla (Fall River, MA)
- …pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP , GDP, and regulatory standards such as FDA 21 CFR Part ... this position. Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing...years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment. Experience in… more
- Aequor (Aliquippa, PA)
- …management, inbound/outbound coordination, and ERP transaction execution-preferably within GMP , biotech, medical device, or other regulated environments. They ... tracker solution to provide real-time visibility of receipt lifecycle status and quality workflow stages. Develop, maintain, and monitor incoming purchase orders and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Analyst is an exempt level ... therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the completion of QC testing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.Expertise in GMP compliance ... understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as… more
- Insmed Incorporated (NJ)
- …technologies and regulatory developments impacting healthcare cybersecurity.Deep understanding of GxP requirements, FDA 21 CFR Part 11, EU GMP Annex 11, and ... maintain governance frameworks and control structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation ... RequirementsBS/BA required in technical discipline: Engineering, science or similar field. GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma… more
- Cipla (Hauppauge, NY)
- …closely working with QA department. Picks materials from Released inventory following GMP rules as required per production schedule, pick list, or production record ... Verifies documentation and reports for accuracy Complies will all aspects of quality management system, cGMP policies, documentation and record keeping in accordance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an ... Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events...of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates… more
- Cipla (Fall River, MA)
- …for this position include but are not limited to the following: The Analytical Quality Assurance (AQA) associate II O III position is an team or individual ... contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA. The job… more
