- Aequor (Phoenix, AZ)
- …and other areas with the calculation of financial impact on opportunities Maintain internal control procedures as well as ensure compliance with SOX Other ... implementation of new accounting rules and guidance for complex transactions, internal controls support, year-end close and audit support, product cost maintenance,… more
- Aequor (Sunrise, FL)
- …Minimum of two years relevant progressive experience in a Quality Control in CGMP pharmaceutical, biotechnology or environmental laboratoryo Experience to Labware ... and regulations. Perform analysis on raw materials, finish goods, API, and control substances Ensures that balances are reviewed and calibrated. Perform peer review… more
- Aequor (Thousand Oaks, CA)
- …position is a business support role in Sample Coordination in Quality Control . It will involve interacting with multiple functional areas including Raw Materials, ... Manufacturing, Stability, Contract labs and internal labs. This role will be both remote and on campus, depending on business need, Monday through Friday, 8 am to 5… more
- Aequor (Framingham, MA)
- …medical devices, pharmaceutical products, biologics and combination products per internal procedures and regulatory requirements. Manage supplies and maintain ... inventory, equipment and tools required for sample room operations . Act as a subject matter expert on sample returns process during audits and inspections. Refer to detailed job description in the attachment. Years of Experience: 2 years of pharmaceutical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … control systems Support technical clarifications with suppliers & internal stakeholders Own self-development & self-initiative to understand the site process ... The Position Assist in the operation, maintenance & system management of process control systems. Assist in managing the uptime & availability of the automated… more
- Merck & Co. (Rahway, NJ)
- …guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices ... and/or department via presentations to governance committees and other internal audiences.Partnering with director-level management to develop and execute scientific… more
- Merck & Co. (Rahway, NJ)
- …strategic plans for problem-solving and continuous improvement by working with internal and external partners.- The key stakeholders include our Company ... risk management programs in development and life cycle management- Utilize design control experience to develop value-add solutions to customer needs in medical… more
- Merck & Co. (Rahway, NJ)
- …process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process ... direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.Lead ... changes within quality systems.Assure equipment maintenance and calibration, and internal audits are performed.Prepare SOPs and specifications. Write memos, reports,… more
- Merck & Co. (South San Francisco, CA)
- …advance drug targets for the treatment of CNS regulation of appetite control , neuronal circuitry in regulation of energy balance, cellular and physiological ... results effectively with stakeholders and present research findings at internal and external meetingsQualifications:Education:Ph.D. in biology, physiology or a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in process validations, and continues with overseeing risk using statistical quality control during manufacturing. In addition, addressing known issues with a strong ... on procedural conformance within the company. The Quality Engineer will participate in Internal Audits as directed by the Quality Manager. In addition, the Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and commercial ... protocols, completed assay data and reports primarily for the quality control laboratories.Key Responsibilities Be responsible for providing quality oversight for… more
- Merck & Co. (Rahway, NJ)
- …product and process development. Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices ... and/or department via presentations to governance committees and other internal audiences. Proactively identifying and escalating program risks. Fostering strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to clinical trial conduct. Major focus is on operations concerning risk control and reporting under RBQM Central Statistical Monitoring during study conduct to ... for the risk-based central monitoring function.Interacts with and influences internal management and study level stakeholders on risk-based quality management… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …through risk monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality Director will represent ... corrective and preventive actions including:Provide management oversight for quality control , batch records, and material review board.Provide management oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of ... handling, techniques, standards, methodologies, and skills in working with internal and external systems, CROs, and vendors. Excellent verbal/written communication,… more
- Formation Bio (New York, NY)
- …production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with regulatory requirements, ... quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements. About… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …is responsible for activities related to technology transfer from external and internal customers. This position will be the liaison between Exela and external ... Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for customers. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial manufacturing. This role ... tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.Routinely… more
- Tris Pharma (Monmouth Junction, NJ)
- …and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on ... relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, accurate, effective and… more
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