- 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
- Compunnel (El Segundo, CA)
- …or Engineering discipline, or equivalent experience in manufacturing with a focus on quality . Knowledge of FDA and ISO compliance, including auditing, SOPs, and ... Familiarity with GMP, GLP, and other quality compliance frameworks. Experience working with quality management software systems. Education: Bachelors Degree more
- Vetio (Jupiter, FL)
- About the job Quality Supervisor (Supplement & Food Safety) SUMMARY: The Quality Supervisor oversees and ensures compliance with FDA 21 CFR Part 111 ... and holding of dietary supplements. This role manages day-to-day quality operations, including batch record review, deviation investigations, internal audits,… more
- Vetio (Jupiter, FL)
- …and wipes at Vetio Animal Health. This role ensures compliance with USP, FDA , and internal quality standards while collaborating with procurement and ... About the job Raw Material Quality Specialist SUMMARY: The Raw Material Quality...judgments, and prioritize workload efficiently. Computer skills required: Spreadsheet Software (Excel) Word Processing Software (Word) Inventory… more
- Santa Cruz Nutritionals (Santa Cruz, CA)
- …Come join us and become a part of our winning formula! The Quality Engineer (QE) supports day-to-day production, continuous improvement activities in the manufacture ... employs process improvement principles, methodology, tools, and techniques in an FDA regulated environment to achieve goals. Interpreting and presenting quality… more
- AbbVie (Pleasanton, CA)
- …skills. Additional Requirements: *Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical ... with preferably no managerial intervention. Qualifications *BS in Mechanical, Software , Electrical Engineering or equivalent degree. Advanced degree desirable. *Must… more
- Yokogawa Electric Corporation (Sugar Land, TX)
- …Procurement and Engineering. Data-Driven Quality Management Implement and manage quality data systems (eg, QMS software , ERP integration). Analyze trends ... and gratitude are highly valued and exhibited in everything we do. The Quality Assurance (QA) Manager is responsible for leading and elevating our quality… more
- BayOne (Raleigh, NC)
- …Experience with FDA , European agency regulations, cGMP regulations, and Quality Management software is highly preferred. Knowledge of regulatory requirements ... 8:00 to 5:00, 3 days a week in the Raleigh office The Associate Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D … more
- Johns Hopkins Healthcare (Baltimore, MD)
- …serves as a primary resource for development and maintenance of Quality Assurance Programs, testing of procedures, special projects, Investigations/analysis and ... in the assessment of QA data. Collects, summarizes and evaluates quality control data, investigating problems and recommending solutions. Assists in development,… more
