- Insmed Incorporated (NJ)
- …Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality Management Systems ProcessesWho You ... other GxP areas, with a focus on data integrity, validation , and inspection readiness. The Sr. Quality ...compliance with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables (eg, URS,… more
- Aequor (Davie, FL)
- …with a focus from University of Miami, FAU, FIU fresh Ph.Ds , and computer science/ automation Master's degree from FAU and FIU.Shift Schedule: Monday - Friday 8 ... and process confirmation studies in coordination with planning, manufacturing, quality , LTS and PM groups. Review and analysis of...of the analytical and statistical data to support the pre- validation work. Analysis of data to ascertain the data… more
- Merck & Co. (Rahway, NJ)
- …Making, Detail-Oriented, Machine Learning, Maintenance Supervision, Manufacturing Process Validation , Manufacturing Quality Control, Manufacturing Scale-Up, ... post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- THE VISUAL PAK COMPANIES (Waukegan, IL)
- …processing quality system policies and procedures. Strong knowledge of Validation protocols, IQ-OQ-PQ Ability to address conflict and resolve well. Detail ... Degree Salary Range $103070.40 - $154605.60 Salary Job Shift 1st Shift Job Category Quality Description Join the PAK The Visual Pak Companies are aligned with many… more
- OPmobility (Archie, MO)
- …of processes using first piece OK, Poke Yoke, SPC, LPA's, and other quality checks. Ensure computer /internet access to Customer Specific Portals and ... training / working skills: 3 years working experience in Quality Engineering IATF16949/CSR (Customer Specific Requirements) ISO 500001/14001 Auditor Blue… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition ... Must be a Team player able to effectively communicate with the fellow IPQA, Quality Control, Production and Supply Chain to meet finished product release goals. Be… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The AD, EDC ... EDC System Design & Development: Lead the setup, development, and validation of EDC systems, including configuration settings, integration with other applications,… more
- Aequor (Davie, FL)
- …Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation (CSV) and documentation practices. Cross-Functional Collaborationo ... Work closely with engineering, IT, quality , and manufacturing teams to align automation strategies with business goals.o Support training and change management… more
- Merck & Co. (North Wales, PA)
- …company clinical trials and assay metadata generated from these collections.Embed automated quality control checks and validation rules directly into data ... 8 years) or Ph.D. (with 4 years) in bioinformatics, computer science, data science, engineering, data analytics, life sciences...backed by an advanced degree in a field like Computer Science, Data Engineering, or Bioinformatics, which you're eager… more
- Merck & Co. (Rahway, NJ)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.-For assigned projects the position serves as the statistical programming ... Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Analysis Reports, Analytical Instrumentation, Chemical Engineering, Chemical Technology, Computer System Validation (CSV), Data Analysis, Equipment ... testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.Document the… more
- Airlite Plastics (Nazareth, PA)
- …strategic priorities of the engineering department to ensure safe, efficient, high- quality production of extruded and injection molded plastic, and expanded ... priorities of the engineering department to ensure safe, efficient, high- quality production. *Continuously evaluate existing processes and systems to identify… more
- Aequor (South San Francisco, CA)
- …complex datasets for deeper analysis.Contribute to the design, implementation, and validation of predictive models using machine learning and statistical techniques ... to client and internal audiences.RequirementsCore QualificationsBachelor's degree in Statistics, Computer Science, Data Science, Psychology, or another field with a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... Training systemsKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsJob duties performed routinely require exposure to and… more
- BioAgilytix (Durham, NC)
- …and the board.Proven track record building cross-functional relationships across Quality , Legal, Finance, Lab Operations, and external vendors.Pragmatic problem ... CSF, GxP/CLIA, Part 11).Business continuity and resilience (eg, backup/restore validation , disaster recovery planning).Minimum Preferred Qualifications - Education/Experience:Bachelor's degree… more
- Amazon Kuiper Manufacturing Enterprises LLC (Redmond, WA)
- …projects in different phases is common; you can demonstrate robust design and validation skills in addition to the understanding of mechanics of ongoing operational ... support productionAbout the teamBASIC QUALIFICATIONS- Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science or related field- 5+… more
- AHU Technologies, Inc. (Washington, DC)
- …potential of mass EV adoption. Through innovation, integrity, and an unwavering commitment to quality and safety, we foster a culture of excellence and trust. If you ... in your workmanship and are committed to upholding the highest safety and quality standards in every task. Leveraging your proven experience in field service… more
- ManTech (Fort Meade, MD)
- …technologies.Design and develop infrastructure solutions using Kubernetes.Develop high- quality software design and architecture.Automate tasks through appropriate ... tools and scripting.Perform validation and verification testing.Document development phases and monitor systems.Minimum Qualifications:Bachelor's degree from an… more
