- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- LEO Events (Chattanooga, TN)
- …manipulate incoming data for internal and client-facing use. *Conduct thorough quality assurance checks on all digital deliverables for accuracy, completeness, and ... *Advanced Excel skills (pivot tables, formulas, conditional formatting, data validation , etc.) *Highly organized with strong attention to detail...of time in a seated position looking at a computer screen. Employee is required to do some standing… 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
- Motiv Electric Trucks (Novi, MI)
- …programs. They work cross functionally with Engineering, Manufacturing, Purchasing, Quality , and Manufacturing organizations to ensure corporate goals, milestones, ... cycles including but not limited to: Supporting prototype builds, testing, and validation to meet production timing Identifying and prioritizing project tasks and… more
