- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key… more
- Twist BioScience (South San Francisco, CA)
- …GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom software and CSV.Experience ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Formation Bio (New York, NY)
- …high-value negotiations with vendors across multiple categories, including software , contract research organizations (CROs), contract manufacturing organizations ... company. Monitor vendor performance and enforce contractual obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areasExperience… more
- Insmed Incorporated (San Diego, CA)
- …and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, ... and maintains detailed records. Analyzing data, preparing reports, and using statistical software for trend analysis are also key duties. Collaboration with R&D,… more
- Eisai, Inc (Nutley, NJ)
- …to the company's products. The incumbent will contribute to the development of high- quality Medical Information deliverables within the team and will be a visible ... to 2 years of relevant experience.Prior understanding and knowledge of FDA guidances on appropriate scientific exchange practices.Demonstrated experience in medical… more
- Aequor (Hicksville, OH)
- …and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.) Note: This position may require the labeling, packaging ... observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient...and recommend improvements. Ability to learn and apply new software multimedia applications Ability to lift up to 50… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and PAS-X/SAP related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control, MSAT, and Engineering to support and improve the planning ... plant, proactively, show a LEAN mindset Interface with Production, Quality Control and Facilities to assist API Planning activities...Knowledge, Skills, and Abilities Knowledge of Cgmp's, ISO and FDA requirements a plus Able to develop and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, ... Engineering, and Quality , and work as part of a cross-functional team...industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and… more
- Aequor (Thousand Oaks, CA)
- …and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc. Determine key ... performance indicators (KPIs) and suggest data-driven improvements Delivering a quality , fit for purpose dataset - plan, build, review with the end in mind (protocol… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for … more
- Genmab (NJ)
- …consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. ... non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA , EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- selection… more
- Omega Medical Imaging LLC (Sanford, FL)
- … assurance experience with Class II electromechanical medical devices, preferably with software . Proven track record navigating FDA GMP/QSR, 510(k) submissions, ... Omega Medical Imaging is the world leader in FDA -cleared interventional X-ray systems with cutting-edge AI-driven radiation reduction technology. We're passionate… more
- Nestle Operational Services Worldwide SA (Gaffney, SC)
- …under the general direction and guidance of the QA Supervisor. The Quality /Lab Technician is responsible for specific activities, as described below, relative to ... incidents Has read and understands the Safety, Health and Environmental Policy Quality : Follow recipes and deviations at all times. Unauthorized deviations are… more
- DeepHealth (Somerville, MA)
- …( FDA and Software as a Medical Device preferred). *Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 ... The Senior Quality Assurance Specialist is responsible for supporting DeepHealth...supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Sr. … more
- Cedent (Brecksville, OH)
- …duties may be assigned. Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA , Notified ... Files. Create and/or modify regulatory procedures to remain in compliance with FDA , ISO, European, Canadian, and other standards. Work with the international… more
- Steris Corporation (Minneapolis, MN)
- …and service solutions around the globe. Position Summary The Senior Product Quality Engineer is responsible for managing processes and leading projects to maintain ... and improve the quality system in accordance with the requirements of, as...the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other… more
- Allen Spolden (Gulfport, MS)
- …relevant applications such as Microsoft Office. Expert knowledge and understanding of quality control, SOPs, cGMPs, OSHA, and FDA policies and regulations. ... on experience. Probably exempt position. The Sr. Microbiologist will provide quality control support to pharmaceutical manufacturing operations by conducting various… more
- Medtronic (Billerica, MA)
- …Nice to Have Experience with manufacturing applications (MES, ERP, Labeling, Quality , Maintenance.) Background in regulated environments (eg, FDA , GMP, ... on-budget delivery of IT projects and strategic programs with first-time quality . Support critical manufacturing applications in collaboration with Apps COE's (ERP,… more
