- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Marotta Controls, Inc. (Parsippany, NJ)
- …of other disciplines when necessary, such as other engineers, manufacturing, purchasing, and quality assurance . Occasional light travel may be involved. + Job ... Jersey Top Workplace three years running! Dedicated to innovation, quality and excellence, we deliver cutting edge control systems...+ Participate in design reviews (internal and external) + Lead failure investigations of designs as required.… 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
- Actalent (Wayne, NJ)
- …+ Leadership skills, with potential mentoring for career progression. + Understanding of Quality Assurance and Validation technical skills. + Ability to act as ... Plan for the packaging facility in collaboration with Engineering Staff, QA Director/ QA Manager, and Compliance Manager. + Lead and coordinate activities for… more
