- Novo Nordisk Inc. (Boulder, CO)
- …standard operating procedures and related forms Works closely with Technical Operations, Quality Control , Regulatory, Supply Chain, and external partners to ... necessary for Quality disposition of clinical intermediates, API and finished drug products at Novo Nordisk Provide QA support for the review of external… more
- Aequor (Thousand Oaks, CA)
- … Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing , Quality Control , Regulatory, Quality Assurance, ... with Supply Chain/ Manufacturing groups to obtain samples, collaboration with Quality Control testing groups, etc.,). Strong project management skills… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from ... Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia...to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …internal audit process. Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality...team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effort will extend to participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the commercial governance ... volume marketed CAR-T product. The validation scope comprises a multi-site global manufacturing network responsible for manufacturing an approved cell therapy… more
- Aequor (Devers, TX)
- …regularly interact with:Reporting ManagerSometimes will interact with departments listed below: Quality Control Manufacturing Operations Manufacturing ... Quality Systems Regulatory expectations Reviews and approves Quality , Quality Control , Validation and...and some project management experience Knowledge of biotech, bulk drug substance or finished product manufacturing , medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as SOPs, work instructions. Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, ... with Environmental, Health, and Safety personnel, Product Development, and Quality / Manufacturing personnel. Independently makes appropriate and compliant GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred. Experience with aseptic processing in ... microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status efforts for ... major equipment, important systems, instrumentation, and computerized systems.Knowledge of quality systems including exception management, change control ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing & Supply lifecycle. This role is pivotal in leading the design ... and execution of the Global Manufacturing & Supply (GMS) data governance process, from material...Work Centers, Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is required Experience in a Quality Control setting is preferred Experience with aseptic processing in ... Sr. QC Analyst (Third Shift) as part of the Quality team based in Raritan, NJ. Role Overview The...Raritan, NJ. Role Overview The Sr. QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for… more
- Tris Pharma (Monmouth Junction, NJ)
- …internal departments (Research and Development (R&D), Supply Chain, Marketing, QA, Quality Control (QC), Regulatory, Packaging, project teams, etc.); ... and components to define needs for brand aesthetics, consumer acceptance, manufacturing capability, quality and cost requirements, sustainability guidelines,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to ... preferably within a biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred. Knowledge of cGMP and GDP… more
- Tris Pharma (Monmouth Junction, NJ)
- …and compliance in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) ... evidence all company equipment is qualified and remains in a state of control to deliver processes and products complying to all regulatory and business… more
- Lundbeck (Bothell, WA)
- …This role will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups so strong interpersonal skills will be beneficial. ... in GMP testing) Oversee routine analytical testing and coordinate study support across Quality Control (QC) and Process Development (PD) groups Oversee routine… more
- Merck & Co. (Rahway, NJ)
- …transfer to GxP laboratories.- He/she will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise ... analytical techniques to solve problems, sound scientific understanding of Critical Quality Attributes and Quality by Design principles, and advanced… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specialist, Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key Responsibilities Develop ... treatment of multiple myeloma. Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. Role Overview The QC… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …time. Collaboration and facilitation: Work closely with Raritan functions, particularly the Quality Control (QC), Quality , and Deviation Investigations ... address bottlenecks. Coordination with Global Teams: Liaise with Global MSAT ( Manufacturing Science and Technology) and ASAT (Analytical Science and Technology)… more
- Aldi (Aurora, IL)
- …* A minimum of 3 years of progressive experience in Food Safety, Quality , Manufacturing , Product Safety, and/or Data Analytics required. * Preventive Controls ... (PCQI), Global Food Safety Initiative (GFSI), Hazard Analysis and Critical Control Points (HACCP), Quality Management Systems, and/or Logistics preferred.… more
