- Merck & Co. (North Wales, PA)
- …limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... Engineering & Quality Assurance is responsible for independent compliance support of Medical...reviews, CAPA reviews, and ad-hoc technical reviews of combination products .Participate in all stages of combo product … more
- Merck & Co. (Durham, NC)
- …with a diversified portfolio of prescription medicines, vaccines and animal health products . The difference between potential and achievement lies in the spark that ... being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors,...across the globe.-The main functions of the Specialist, Quality Assurance is to assist in the review of batch… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with ... Person in Plant (PIP) activities when packaging operations for DSI are in- process . Supports investigational product distribution activities at the vendor,… 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
- 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 ... Quality Assurance Document Control Supervisor Position Summary Catalent Pharma...approving batch records, and releasing batch records and finished product . They will have a deep understanding and values… 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
- 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 (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... function.The Product Development QA Manager provides quality focused customer service , with the highest integrity, in partnership with Catalent St. Petersburg's… 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. (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
- Merck & Co. (Rahway, NJ)
- …the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable ... industry best-practicesExperience 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)
- …CQV program to enable robust production, testing and release of product to patients. Key Responsibilities Executes the commissioning, qualification, requalification, ... Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews Requirements A minimum of a Bachelor's Degree in Science,… 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. (Rahway, NJ)
- …approval of potential new drugs, vaccines and new indications for existing products . We ensure we conduct high quality clinical trials by integrating ... revision of quality agreements with business partners (ie co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements… 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
- Eisai, Inc (Nutley, NJ)
- …ability considering quality, cost, and speed.Broad understanding of IT technology platforms, products , and services . Leadership and Teamwork Strong track record ... policies based on regulatory changes.Establish a regulatory change management process for modifying technological functions and compliance controls.Monitor and test… more
- Merck & Co. (Rahway, NJ)
- …concepts.Hands on experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... point of contact and knowledge holder through the entire product lifecycle.Primary Responsibilities:Effective analysis and report programming development and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, Informatics ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads… more
- Catalent (St. Petersburg, FL)
- …network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.Catalent is ... employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department… more
