- 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
- 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
- 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
- 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
- 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
- City of New York (New York, NY)
- …senior 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
- 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
- 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
- SMBC (Jersey City, NJ)
- …performing investigations and supports certain watchlist management processes. Associates in the Investigations teams help lead the team on the behalf of the ... manages sanctions risk from a second-line of defense perspective. Investigations is a team within the SCT which is...other functions. Can provide training for others and may lead a process involving a team, and acts as… 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
- Catalent Pharma Solutions (Princeton, NJ)
- …Manufacturing Associates on aseptic techniques, processes, and compliance expectations. + Lead or support investigations , deviations, CAPAs, and batch record ... Manufacturing. **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and… 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
- Pfizer (New York, NY)
- …of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices + Demonstrated technical know how + Proven ... and that all required escalation processes are followed. + Lead and support complex investigations , market complaints,...application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and… more
- City of New York (New York, NY)
- …priority for the Agency. IHD's Engineering Services includes the Quality Assurance , Laboratory Services, Specifications/Standard Operating Procedures, ... all New Yorkers by providing 1.1 billion gallons of high- quality drinking water, managing wastewater and storm water, and...the Section Manager, the selected candidates will take the lead in the delivery of the capital projects through… more
- WSP USA (New York, NY)
- WSP is seeking a ** Lead Structural Engineer** to join their dynamic **Property & Buildings** team in **New York ,NY.** Our team is a leading provider of structural ... are delivered and adhered to with a level of quality that meets or exceeds acceptable industry standards for...+ Analyze, evaluate, and interpret data obtained during site investigations , offering input with developing action plans for moderate-… more
