- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Deviation Management, Equipment Qualification, Facilities Engineering, GMP Compliance , Good Manufacturing Practices (GMP), Maintenance Processes, ... for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops… more
- Merck & Co. (Rahway, NJ)
- …Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ 4 ... leading a team for a common goal-Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation… more
- Merck & Co. (Rahway, NJ)
- …in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and related documents ... findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, ... This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development… more
- Aequor (Thousand Oaks, CA)
- …of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area ... SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions in order to ensure compliance . Experience managing… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Environments, Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, ... will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices… more
- Merck & Co. (Rahway, NJ)
- …Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance , Regulatory Compliance {+ 3 ... establish boundaries and ground rules for engagement with the EPs, while ensuring compliance / quality readiness of these suppliers at all times through the… more
- Merck & Co. (Rahway, NJ)
- …leverage advanced computational modeling and simulation tools to support pharmaceutical reserachers in predicting drug behavior, improving descision-making, and ... regulatory audits and inspections by collaborating with stakeholders and Quality units to provide documentation and respond to inquiries.Actively drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to ... systems records.Support CAPA site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing… 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 ... and optimization of HVAC systems for both commercial office buildings and pharmaceutical laboratories at the Rahway, NJ Site.Develop, implement, and maintain HVAC… more
- Tris Pharma (Monmouth Junction, NJ)
- …and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including ... Response Letters (CRLs)Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans… more
- Merck & Co. (Rahway, NJ)
- …reduce costs, minimize experimental batches, shorten timelines, and improve product quality and process robustness. Communicate complex modeling insights clearly to ... years of relevant experience in Chemical, Biochemical, Mechanical, Biological, Pharmaceutical Engineering, or related fields.Strong research background in computational… more
- Merck & Co. (Rahway, NJ)
- …to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak identification, ... chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and business improvements.Demonstrate the ability to influence meaningful… more
- Aequor (Swiftwater, MN)
- …This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... Quality and Raw Materials. This position requires proficiency and...Validation, Independent Demand, and Stability program. Maintain safety and compliance of the laboratory work area. Perform cleaning of… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio) pharmaceutical and medical device industries to set tactical and strategic direction ... on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... organizations, and study investigators- Manage vendor budget and activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (North Wales, PA)
- …benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling ... the development of programming standards to enable efficient and high- quality production of programming deliverablesProduce SAS transport files and associated… more
- Merck & Co. (Durham, NC)
- …and implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance :The successful candidate should be able ... Technician Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Requirements:Must have at least 6+ years of professional experience in Quality and clinical development in the Pharmaceutical industry, with ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
