- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborating with a variety of cultures and communication styles- Conducting Business Analysis and/or Business Process Engineering- Working in a global ... disorders. We are currently seeking a Global DX Project Assurance Intern from June 2026 - May 2027. This...issue management and resolution abilities.- Solid understanding of business analysis , process engineering, and financial management for… more
- 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
- Twist BioScience (South San Francisco, CA)
- …completion of responsibilities.What You'll Bring to the Team Bachelor's degree in Engineering, Quality Assurance , or a related field.5+ years of experience in ... prevent recurrence of non-conformities.Provide technical support to the R&D team on quality matters, including design control, process validation, and change… more
- Cipla (Fall River, MA)
- Job Title: Analytical Quality Assurance Supervisor 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: $78,000 - $99,840 Purpose This position requires a strong analytical… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance (QMS) Production Lead FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - ... To : QA Manager Purpose: The purpose of the Quality Assurance Production Lead (QMS) is to... is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with a high degree of accountability.Proficient knowledge of Microsoft Office.Experience in quality metrics reporting, analysis and process improvement ... the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… 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
- Merck & Co. (North Wales, PA)
- …Risk Management, Complaint Management, Cross-Functional Teamwork, Data Quality Assurance , Drug Development, Economic Impact Analysis , Exercises Judgment, ... Machine Learning, Maintenance Management, Oncology, Periodic Reports, Pharmaceutical Management, Process Improvement Projects, Process Improvements, Quality … 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 (Fall River, MA)
- …deviations, non-conformances, and CAPAs (Corrective and Preventive Actions). Work closely with Quality Assurance (QA) to ensure adherence to standard operating ... Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues… 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
- 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
- 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. (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
- Tris Pharma (Monmouth Junction, NJ)
- …and managing SKU-level inventory accuracyCollaborates cross functionally with Supply Chain, Quality Assurance and Operations teams to resolve scheduling ... demand forecasts and inventory targets while supporting and following manufacturing quality controls and procedures in accordance with Standard Operating Procedures… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis and corrective/preventive actions (CAPA) related to HVAC system failures or… 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
