- Insmed Incorporated (NJ)
- …activities.Support investigations and root cause analysis of product or process issues related to clinical manufacturing.Drive Quality input into lifecycle ... degree (MS, PhD, PharmD) strongly preferred.Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least… more
- Repligen (Hopkinton, IA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Memorial Healthcare System (Pembroke Pines, FL)
- …and ultrasound equipment and reporting system service, maintenance, and upgrades for quality assurance . Prepares and maintains written documentation as required ... and/or reports equipment malfunctions as necessary. Competencies: ACCOUNTABILITY, ACCURACY QUALITY , CUSTOMER SERVICE, IMAGE PRODUCTION, ANALYSIS AND ARCHIVAL,… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 -... is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating… more
- Insmed Incorporated (NJ)
- …QC data or practices from external labs.Collaborate with Analytical Development, Quality Assurance , Regulatory Affairs, Supply Chain, and other departments ... for the future of science, we're in. Are you?About the Role:The Associate Director, Quality Control will be responsible for leading and overseeing all Quality … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Audit and Assurance Services primary purpose is to provide value-added independent and risk-based audit and assurance ... operational, SOX 404 and IT audits, integrated audits and process audits, both domestic and abroad to maintain a...walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in… more
- Merck & Co. (North Wales, PA)
- …ADaM), Define.XML, SDRG, ADRG also required.Must possess demonstrated success in the assurance of deliverable quality and process compliance.Excellence in ... and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance-and data fitness.Act as a key collaborator… more
- Cipla (Fall River, MA)
- …implement procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA). Check and monitor for cleanliness, maintenance, ... is preferred. Minimum of two to three (2-3) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment. Technical… more
- Merck & Co. (Rahway, NJ)
- …root cause analysis and targeted coaching.Review interactions to identify quality gaps, training needs and process improvements.Use Salesforce and data ... reviews, amendments and renewals with procurement and legal.Lead customer communications and quality assurance for phone, chat and email.Define and enforce… more
- Merck & Co. (Rahway, NJ)
- …controls, risk analysis , control strategies, design verification testing, and process validation, with a strong understanding of quality management systems ... members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance : Ensure that all activities are conducted with… more
- Cipla (Hauppauge, NY)
- …in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during ... packaging, as per manufacturing & batch packaging record instructions. Collection of in- process blend, finished product, validation samples for analysis , sample… more
- Cipla (Hauppauge, NY)
- …in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during ... packaging, as per manufacturing & batch packaging record instructions. Collection of in- process blend, finished product, validation samples for analysis , sample… more
- Merck & Co. (Rahway, NJ)
- …data management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic ... projects. -Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Cipla (Hauppauge, NY)
- …in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during ... packaging, as per manufacturing & batch packaging record instructions. Collection of in- process blend, finished product, validation samples for analysis , sample… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirementsPreferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. ... projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis … more
- Merck & Co. (Biloxi, MS)
- …needed, to aid in delivery of product to customers, ie International Registration, Quality Control, Quality Assurance , Production, etc. to align veterinary ... in the development of new products when needed, product use directions, quality control in application of vaccines, adverse event reporting in accordance with… more
- Cipla (Hauppauge, NY)
- …Job Overview Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering and ... validation studies, and assurance that the necessary project documentation is complete, accurate...FATs/SATs etc. Perform work to meet company' requirements and quality standards. Represent facility and engineer to communicate with… more
- Merck & Co. (North Wales, PA)
- …programming team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also ... the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance.Responsible for effective deliverable development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... and review of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.].Support Sourcing & Procurement team on implementing supplier performance metrics [e.g. Assurance of Supply, Quality , Service, Cost & Innovation] and ... activities - inclusive of Purchase Order (PO) creation and management, cost analysis , inventory and vendor management - in accordance with company policies and… more
