- Aequor (Athens, GA)
- …sites / activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy ... systems . Electronic Document Management (controlled documents, regulatory submission documents): Create...systems . Must be able to follow precise computer system instructions with high attention to detail and minimal… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Durham, NC)
- …a respirator.--Computer literacy (internet browsers, e-mail, spreadsheets, word processing).- Preferred Experience:Associate degree in electrical, electronic ... Managing Engineering Teams, Mechanical Maintenance, Metrology, PLC Programming, Pneumatic Systems , Preventive Maintenance {+ 2 more}- Preferred Skills:Job Posting… more
- Merck & Co. (Omaha, NE)
- …using standard problem-solving tools and methods to resolve machine and system issues.Experience with pneumatic and electronic controls, wiring methods, ... Engineering Teams, Mechanical Maintenance, Operation Maintenance, PLC Programming, Pneumatic Systems , Preventive Maintenance, Production Operations {+ 4 more}- Preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred Experience10+ years of experience in GxP-regulated IT… more
- Merck & Co. (Durham, NC)
- …Environment and Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance, Systems Troubleshooting {+ 3 more}- Preferred Skills:Job Posting End ... monitoring during processing and records results in the computerized database system . Provides timely delivery of samples and other materials as required… more
- Repligen (Rancho Dominguez, CA)
- …9001 and GMP manufacturing standards. Proficient in SolidWorks/CAD, MS Office, and electronic file management systems . Familiarity with single-use systems , ... device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO… more
- Repligen (Hopkinton, IA)
- …documentation in a timely manner to meet established deadlines (paper and electronic ).Maintains related database systems , if applicable, logs and complete ... is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document control department in… more
- Genmab (NJ)
- …submission-ready labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance ... effortsRequirementsBachelor's degree in a scientific discipline is required; PharmD/PhD preferred .3-5 years of pharmaceutical industry experience preferred ,… more
- Merck & Co. (Durham, NC)
- …lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. ... requirements toward analytical testingCapability to function effectively within an automated/ electronic laboratory environmentThis position will be located at the… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... experience at the leadership level including the development of electronic submission deliverables.Designs and develops complex programming algorithms.Ability to… more
- Everglades Equipment Group (Fort Myers, FL)
- …Certification in automotive air-conditioning Read hydraulic schematics and diagnose hydraulic system faults Read electrical schematics and diagnose electronic ... basic mechanical to complex technical diagnostics of modern computerized systems . Must be able to provide own basic tool...telematics, desirable Strong communication skills, great sense of humor preferred Must be able to maintain files Basic Data… more
- Aequor (Thousand Oaks, CA)
- …of quality systems . Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality ... in a relevant scientific field (eg, biology, chemistry, biochemistry) is preferred , direct industry experience is more important. Candidates should be familiar… more
- Merck & Co. (Upper Gwynedd, PA)
- …responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS CMC ... a biological science, engineering, or a related field (advanced degree preferred ). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or… more
- Twist BioScience (South San Francisco, CA)
- …Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience ... Products required. Experience with Master Control, Atlassian Confluence and/or JIRA preferred . Strong written and oral communication skills (timely, clear, concise,… more
- Merck & Co. (Rahway, NJ)
- …Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems , Electronic Common Technical Document (eCTD), ... Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ 4 more}- Preferred Skills:Job Posting End Date:08/4/2025 *A job posting is effective… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms ... and industry best-practices Ability to anticipate stakeholder requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable… more
- NYULMC (New York, NY)
- … Qualifications: OCN certification preferred . CCRP, CCRC and/or CRN-BC certifications preferred . Experience with EPIC electronic health record preferred . ... per the protocol requirements, including but not limited to a Review of Systems (ROS), baseline and ongoing AE assessment and documentation, and collection of… more
