- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... Actively seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design,… 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
- 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
- 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
- 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
- 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
- City of New York (New York, NY)
- …clearance results. - Responsible for the maintenance of confidential records for all investigations performed. - Performing quality assurance review of ... covers a broad range of subject matter, including oversight of environmental investigations , lead poisoning, injury prevention, occupational health, food safety,… 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
- City of New York (New York, NY)
- …management, and Mayor's Monthly Management Report. - Review and analyze inspection and quality assurance reports submitted by APHS I and make sound ... covers a broad range of subject matter, including oversight of environmental investigations , lead poisoning, injury prevention, occupational health, food safety,… 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
- City of New York (New York, NY)
- …community priorities. OCEP is recruiting a candidate for the Senior Officer for Strategy and Quality Assurance . The individual will lead the team's work for ... implementation, and contract deliverables (including budgets). They will have led quality assurance , program improvement and evaluation initiatives, designed… more
- Bristol Myers Squibb (Summit, NJ)
- …programs. + Assures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, ... our Cell Therapy team. The 2nd Shift Senior Manager, QA Disposition Daily Operations is responsible for leading the...policies, standards, procedures and global cGMPs. This individual will lead a team responsible for ensuring timely and accurate… more
- Merck (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... seek out, anticipate, and solve significant scientific and technical challenges. + Lead complex investigations into technical challenges related to design,… 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
