- Merck & Co. (Rahway, NJ)
- …- Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API manufacturing in a complex, clinical ... quality review and approval of batch records, testing data , and related documents required to release or reject...with all stakeholders in all manufacturing operations, analytical testing, quality assurance , regulatory, etc. at all levels.… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Rahway, NJ)
- …submission process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. ... patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight… more
- BioAgilytix (Durham, NC)
- … data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet ... systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Aequor (Thousand Oaks, CA)
- …sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance ... be responsible for the maintenance of training records, recording and computing data . Ability to maneuver 50&plus pounds General understanding of aseptic techniques,… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... 5+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier … more
- Formation Bio (New York, NY)
- …contractual obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and ... with company policies, industry regulations (eg, FDA, EMA, GxP), and data security requirements. Identify opportunities for cost savings, contract optimizations, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Aequor (Houston, TX)
- …and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... the compiled final report o Displays ability to gather data from various sources across the site, performance of...to work well within a team. Routine interaction with Quality Assurance and other Quality … more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… 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 ... systems. Manage the development and oversight of site operations through data analytics.Establish and monitor key performance indicators (KPIs) for HVAC system… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... utilities, and facility qualification, process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... in liaison with PD/QA/QC/Regulatory AffairsDesigns experimental plans; Critically analyzes data and information gathered during method validation for possible… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... time constraints, while maintaining a high level of work quality .Ability to present scientific data and concepts...level of work quality .Ability to present scientific data and concepts to CMC team members and leadership.Knowledgeable… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Repligen (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both ... to an individual's qualifications, location, internal equity, and alignment with market data . Additionally, employees are eligible to participate in one of our… more
- Merck & Co. (North Wales, PA)
- …requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge ... in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical… more
