- 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
- 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
- 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
- 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
- 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. (Upper Gwynedd, PA)
- …Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process ... to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC… 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)
- …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
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance .The essential requirements of the job include:Degree ... and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical , related life sciences or other regulated industries.It would be a plus if you… 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
- Cytiva (Miami, FL)
- …instructions and cross train as a backup for other QA members.Participate in quality walks and internal audits to ensure compliance with industry standards.Who ... life-changing career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for the… 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
- 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
- Eisai, Inc (Indianapolis, IN)
- …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 ... of representatives selling efforts in accordance with strategic plans and compliance , monitoring and driving sales goals, and coaching Sales Representatives on… more
- Eisai, Inc (Nutley, NJ)
- … compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & ... 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… 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
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