- 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)
- …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
- 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
- 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
- Integra LifeSciences (Plainsboro, NJ)
- …The lead associate is responsible for performing and/or scheduling quality assurance inspections on purchased components, manufactured sub-assemblies and ... patient outcomes and set new standards of care. The ** Lead Quality Inspector** serves as a ...non-conformances in timely manner. + Support NCs and CAPA investigations as required. + Assist with product flow between… 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
- Cardinal Health (Trenton, NJ)
- …in and hosting internal/external client calibration sessions. + Engage in and lead projects to promote quality enhancements and/or broaden services for ... remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer...standards, and operating procedures. + Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.… 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
- Capgemini (Bridgewater, NJ)
- …or being presented. Play a pivotal role contributing to quality assurance of Analyst write-ups and investigations . Provide teach backs, spot-checks, and ... and kept up to date by Supervisor. Take the lead on any investigations which require further...and more effectively while maintaining a laser focus on quality ). CREDENTIALS: A bachelor's degree or equivalent experience is… more
- BD (Becton, Dickinson and Company) (Branchburg, NJ)
- …collaborates with Technology Development and Operations functions and acts as the technical lead within QA department to work with engineering on review of ... Provide problem solving and root cause analysis expertise to lead / support OOS/Deviation/CAPA investigations + Review...investigations + Review Test Method Validation and provide quality expertise in the development of test methods and… more
- J&J Family of Companies (Titusville, NJ)
- …Learning, Management Systems Implementation, Operations Management, Process Improvements, Prototyping, Quality Assurance ( QA ), Robotic Automation, Science, ... sites, and partners. Daily, the Senior Manager partners with Operations, MSAT, IT, Quality , 3rd party partners, and Environment Health & Safety. The Senior Manager… more
- ISC2 (Trenton, NJ)
- …of emergent technologies like Large Language Models (LLMs) and AI to enhance the quality assurance process.The Exam Content Process Manager must not only serve ... construction as well. The incumbent will be required to lead groups of subject matter experts from all over...Large Language Models (LLMs), particularly for content analysis and quality assurance , is highly desirable. **Education and… 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
- Sokol Materials & Services (Skillman, NJ)
- …The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance , Quality Control, Supply Chain, and ... plans and other risk mitigation exercise as part of investigations (eg Root cause analysis and CAPAs). + Experience...in a highly dynamic environment. + Basic knowledge of quality by design and risk management. + Basic experience… more
- J&J Family of Companies (Raritan, NJ)
- …tasks according to objectives, and provide problem resolution is required + Experienced quality assurance /compliance mindset is required + Has a data driven ... technical assessments for non-conformances related to starting materials and support failure investigations (incl. escalation of quality or compliance events) +… more
- BeOne Medicines (Pennington, NJ)
- …and support. based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued ... process verification, investigations , change management and site startup of Hopewell internal...**Leadership:** + Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy and… more
- Lilly (Branchburg, NJ)
- …operations. This position will interact with the engineering, manufacturing, validation, quality assurance , quality control and regulatory departments. ... Communicates issues in a timely manner. Assists during process-related investigations and assesses technical impact. Serves as a key...strategies for Lilly Branchburg processes. 9. As required, may lead or assist in the planning and execution of… more
- J&J Family of Companies (Raritan, NJ)
- …and process validation. Directs workflow of systems and processes that follow quality assurance best practices for manufacturing, including documentation and ... of testing. + Approve QC microbiology laboratory data. + Initiate and approve quality investigations , CAPAs, and change controls related to microbiology. +… more
- Astrix Technology (Middlesex, NJ)
- …+ Ensure full compliance with company policies, operational standards, and quality assurance protocols. **Requirements:** **Education and Experience:** + ... in the development and execution of purification processes to ensure consistent, high- quality results. + Utilize operational systems to monitor and analyze data,… more
