- Catalent (Philadelphia, PA)
- …files, review and approve batch records, and release batch records and finished product . The Quality Assurance Document Control individual acts as the primary ... Job Description Quality Assurance Document Control Position Summary: Catalent Pharma Solutions...network. Packaging can be configured to hold a single product or multiple products as determined by… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities requiring support include… more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II ... This will include documentation review and approval, dispositioning of product or its intermediates & supporting manufacturing operations.This position is… more
- Catalent (San Diego, CA)
- …process QA activities, including line clearance and room release, in- process and receiving inspections, and raw material/ product sampling.Implement Global ... Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership… more
- Catalent (Philadelphia, PA)
- …internal and or external business challenges and/or regulatory Issues; recommends process , product or service ImprovementsPerform all related ... QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production...network. Packaging can be configured to hold a single product or multiple products as determined by… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing ... bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP… more
- Merck & Co. (North Wales, PA)
- …(SME) for medical review.Serve as product SME during GMA global assurance process for country assessment.US and Global Medical Information-Leverage clinical ... Management Safety Team(s) when required.Act as SME for creation/update of GMA process /SOPs.Engage in Medical Significance Assessments of company products as it… more
- Catalent (St. Petersburg, FL)
- …process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive ... Product Batch Release, and Change Control.The QA Product Manager provides customer service , with the...Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including… more
- Merck & Co. (Ames, IA)
- …on the Dairy Industry. Responsibilities include providing technical support for Ruminant products and programs, including response to product inquiries and ... and market intelligence data. Using this data, we design, develop and deploy products , platforms, brands and marketing initiatives that ensure we can improve the… more
- Catalent (Philadelphia, PA)
- … throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual ... the Quality Supervisor. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties...needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time… more
- Merck & Co. (North Wales, PA)
- …speed-to-market while ensuring sustained compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. This leader will ... quality management system and ensure strategic quality oversight of new modalities products manufactured in the network and at external partner sites. The leader… more
- Catalent (Manassas, VA)
- …This position also requires Quality Control data base management and control over product specifications. The SQF process is broad in scope and requires ... we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.The Quality Assurance… more
- Catalent (St. Petersburg, FL)
- …of non-commercial products and materials. The department provides analytical services to manufacturing, process development, validation and new material ... laboratory that supports evaluation and testing of raw materials, excipients, APIs, in- process and finished product samples. AR&D also performs development and… 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 to ensure ... (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation,… more
- Merck & Co. (North Wales, PA)
- …and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and ... the preparation and submission of CMC sections for commercial or new biologics products . The Principal Scientist will lead the development and the implementation of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, NJ Legend manufacturing site. Key Responsibilities ... for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …include Disposition activities , including incoming materials and final drug product , QA shop floor oversight of manufacturing operations, Quality Assurance ... the daily quality activities for the quality operations team to ensure facility, process , and materials are in compliance with cGMP requirements. Partners with other… more
- Merck & Co. (North Wales, PA)
- …through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable development ... industry best-practices.Experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a cell ... activities. They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.Key… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with other local SMEs in IT/OT, System Managers, and IT QA Maintain IT services and operations according to service level agreements and contracts, performing ... manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's… more
