- 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)
- …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
- 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
- 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
- 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
- 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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance + Very experienced in Quality Council ... Councils. + Support CAPA management by facilitating root cause investigations , review and approval of CAPA plans + Partner...of education, training, and experience + Minimum 10+ years QA experience or relevant experience in quality … 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
- 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
- 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
- Astrix Technology (New Brunswick, NJ)
- **QMS Supervisor - Biologics Manufacturing** Quality Assurance Middlesex County, NJ, US Pay Rate Low: 90000 | Pay Rate High: 105000 + Added - 03/10/2025 Apply ... for Job We are seeking an experienced Quality Systems/QMS Supervisor to lead ...investigations , CAPA, documentation control, and report writing. + Lead and manage PPQ and cleaning validation projects to… 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
- GE Aerospace (Trenton, NJ)
- …work scope, standards, load reduction, and growth. **Job Description** **Roles and Responsibilities** + Lead Quality Assurance and Supplier Quality Team ... Team Leader for Nacelles & Non-Destructive Evalution will lead a team of quality and technology...quality initiatives, projects, root cause and corrective analysis investigations , and more + Impacts the team's ability to… 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
