- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental… more
- Twist BioScience (South San Francisco, CA)
- …and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements and ... Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets… more
- Merck & Co. (Rahway, NJ)
- …Quality Assurance:Ensure that all activities are conducted with the highest regard for safety , quality, and regulatory compliance , aligning with the ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
- Merck & Co. (Durham, NC)
- … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Merck & Co. (Millsboro, DE)
- …Manufacturing Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance , Safety Practices, Science, Standard ... including charts, log books, and all pertinent documentation.-Identifies and addresses compliance , environmental, safety , and process deviations as appropriate… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up… more
- Merck & Co. (Rahway, NJ)
- …management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process ... Sciences, Phytochemistry, Process Control Automation, Process Optimization, Process Simulation, Product Formulation, Safety Compliance , Standard Operating… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... line and monitors for defects. Inspects filled container or package to ensure product is according to specifications. May weigh finished products to detect missing… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... filling and packaging operations. Major Accountabilities Supplies production line with product and packaging components as required. Loads and unloads components or… more
- Insmed Incorporated (San Diego, CA)
- …technology transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits ... support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves hands-on… more
- Merck & Co. (Rahway, NJ)
- …Critically, the individual will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive ... Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory CMC,… more
- Merck & Co. (Durham, NC)
- …scorecard to address local business, service and operational challengesQuality & Safety Compliance :Develop and execute engineering change request (ECRs), as ... successful candidate should be able to examine an issue from diverse perspectives ( safety , compliance , automation, equipment, process, and people) in order to… more
- Merck & Co. (Rahway, NJ)
- …work in applying regulatory guidance and quality standards related to product release and safety .Current Employees apply HERE Current Contingent Workers ... of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Durham, NC)
- …and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk-based approach ( Safety Regulations, Quality ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Eisai, Inc (Phoenix, AZ)
- …Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. ... understanding of issues and opportunities in territory. Deliver clinical, efficacy, and safety messaging and information about product access / safe… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
