- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and ... validation , shipping validation , and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation ,… more
- Merck & Co. (Rahway, NJ)
- … Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across ... and instrumentation in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for… more
- Twist BioScience (South San Francisco, CA)
- …Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and ... analytics, and data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES… more
- BioAgilytix (San Diego, CA)
- …specification, IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, ... with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP… 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
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Ability to perform routine… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.-Position Description-This is a… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12 ... and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of… more
- Merck & Co. (Durham, NC)
- …empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a night shift position, 12 ... and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of… 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 ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Aequor (Hicksville, OH)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... feedback on operator performance. Interacts with production management, mechanics, and Quality Assurance. Participates in training of new employees. Adheres to all… 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
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (Rahway, NJ)
- …for statistical programming deliverables. Contribute to the development and validation of datasets following CDISC standards. Generate tables, listings, and ... files and program text files for regulatory submission. Assure high quality and timely deliverables. Communicate and collaborate effectively with project team… more
- Merck & Co. (Rahway, NJ)
- …submission deliverables under the guidance of a senior level programmer.Perform validation tasks according to departmental SOPs and collaborate effectively with ... transport files and associated documentation for regulatory submissions.Assure deliverable quality and compliance with departmental SOPs and good programming… more
- Lilly (Pleasant Prairie, WI)
- …field. + 2+ years of relevant work experience in information technology, engineering, computer system validation , quality control support or related areas. ... Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and Data integrity...procedures to be audit ready, mitigate risk and follow quality management practices. Support and abide by applicable Lilly… more
