- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... Excellence Team. The QA Investigations Lead is responsible for providing quality oversight...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations , assist or lead in the prompt implementation of ... process parameters, improve manufacturing yields, reduce scrap, conduct non-conformance investigations , and execute CAPA project work which supports manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all manufacturing record which will involve binding and archiving and storage.Support Investigations team by providing quality and compliance input for ... continuous improvement and remediations; also, support or facilitate investigations for Product Quality Complaints.Review, revise, or draft Standard Operating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution,… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). + Demonstrated ability to lead QA medical device and combination products compliance and auditing ... related to medical device and combination products (FDA/ISO). + Lead Management Review meeting ensuring the Quality ...detail. + Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.… more
- BeOne Medicines (Pennington, NJ)
- …processes including final formulation, parenteral vials and lyophilized products. + Lead investigations and resolve complex manufacturing issues. + Manage ... BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This involved cross collaboration of team with multiple organization particularly investigations , manufacturing, technical support and QA .Ensure MES team can ... of the MES organization. Role will work collaboratively with Operations, IT QA , Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …materials, in-process and final products to ensure compliance with cGMPs, GLPs, ISO Quality Assurance Procedures, SOPs and established deadlines + Establish and ... Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to...+ Direct and close all QC Stage 1 OOS investigations , deviations, CAPA, and QA investigations… more
- iconectiv (Bridgewater, NJ)
- …memos, reports, and correspondences + Experience with reporting, metrics, SLA management, and quality assurance + Strong organizational skills and the ability to ... in Change Advisory Board (CAB) discussions where required + Lead and support root cause investigations and...required + Lead and support root cause investigations and contribute to post-incident reports to improve long-term… more
- Cardinal Health (Trenton, NJ)
- **_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure ... products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality … more
- US Foods (Perth Amboy, NJ)
- …prioritization and action planning, and preparing to support during labor negotiations. Lead thorough investigations when assigned and partner with Compliance on ... dynamics while maintaining a market focus. + **Special Projects:** Lead or support special HR projects aimed at improving... investigations they lead ; effectively summarize findings and provide recommendations for employee… more
- Cardinal Health (Trenton, NJ)
- …therapies to patients who need them-faster.** **_Responsibilities_** The primary function of the Quality Assurance Analyst is to deliver high quality service ... hosting internal/external client calibration sessions. + Engage in and lead projects to promote quality enhancements and/or...with a proven ability to develop and execute effective quality assurance programs. + Works independently within… more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job Location...Provide QA support to the Devens site and QA Manager by reviewing and approving investigations and ... GXP with at least 8 years focused on product quality . Preferred Active member of ASQ or ISPE. +...* Provide guidance and coaching to other teams on investigations , CAPAs, risk assessments, and validation processes. * Analyze… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …manufacturing operations at CDMOs, including review of batch records, deviation investigations , and change controls. + Lead or significantly contribute ... for downstream processing (chromatography, TFF/UFDF, viral clearance/filtration, etc.). + Lead and manage the technical aspects of downstream process technology… more
- Actalent (Princeton, NJ)
- …batch record review, aseptic operations, and environmental monitoring. + Demonstrated ability to lead and close complex quality investigations including root ... cell therapy experience. + 3-5 years of GMP manufacturing experience. + Experience in Quality Assurance oversight for manufacturing floors. + Proficient in ISO 7… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …reduction where appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance , Regulatory Affairs, and Operations to align strategies ... contact for CDMOs regarding process performance, troubleshooting, and improvements. + Lead complex manufacturing investigations and deviations, ensuring thorough… more
- J&J Family of Companies (Titusville, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job ... facility. The position holder will have signatory authority for QA in those projects. + Support or lead...attitude. + Extensive knowledge and full understanding of the Quality Assurance tasks associated with of pharmaceutical… more
- WSP USA (Lawrenceville, NJ)
- …USA is initiating a search for a Full-time **Electrical/ Critical Systems'** ** Lead Commissioning Agent** for our **New York** office. Other office locations ... are delivered and adhered to with a level of quality that meets or exceeds acceptable industry standards for...regulations. + Ability to plan and conduct inspections and investigations on various aspects of the installation and design… more
- ConvaTec (Bridgewater, NJ)
- …business administration (desirable) or any other related grade. + Knowledge of the Quality Assurance standard for medical devices like ISO13485 and 21 CFR ... This function is responsible for the management and overseas of the Quality Systems. Responsible for developing, identifying, analyzing, and improving the quality… more
