- Formation Bio (New York, NY)
- …to join the Data Platform team at Formation Bio to help transform Electronic Health Records (EHR) data into structured, analytics-ready assets. In this role, you'll ... be partnering closely with our Data Science team to model, transform, and refine data for operational and scientific use cases.This position sits at the intersection of healthcare data engineering, modern data platform infrastructure, and generative AI. While… more
- Merck & Co. (Rahway, NJ)
- …and leverage departmental standards and industry best-practicesProgramming expertise with electronic healthcare databases ( electronic medical records and ... vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience eliciting user requirements and documenting programming… more
- Everglades Equipment Group (Boynton Beach, FL)
- …and diagnose hydraulic system faults Read electrical schematics and diagnose electronic faults Experience in diagnosing and repair of diesel engines Experience ... with telematics, desirable Strong communication skills, great sense of humor preferred Must be able to maintain files Basic Data Entry and write reports Must be able to work in a fast paced, extreme environmental conditions and meet deadlines Team builder Self… more
- Cipla (Hauppauge, NY)
- …compliance with 21 CFR Part 11 requirements, particularly ensuring that electronic signatures, timestamps, and system access are appropriately documented and ... and associated audit trails comply with 21 CFR Part 11 requirements for electronic records and signatures, ensuring that all system actions are secure, traceable,… more
- Merck & Co. (Durham, NC)
- …a strong working knowledge of computers including Microsoft 365 suite and electronic medical records. Responsibilities include, but are not limited to: Occupational ... preferred. #MSJR Required Skills: Collaborative Communications, EHS Program Management, Electronic Medical Records (EMR), Health Education Promotion, Immunizations, Incident… more
- Eisai, Inc (Nutley, NJ)
- …for all of Eisai's products.Maintain centralized labeling repository within Eisai's electronic document management system for all global labels at various stages ... approval. Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.- Positions may ... of inspection results and maintain accurate records of findings in an electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.- Positions may ... maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.Maintains detailed knowledge of process equipment and operations.-… more
- Insmed Incorporated (NJ)
- …requirements (FDA, EMA, Health Canada, MHRA, etc.) for electronic submissions.Maintain submission timelines, submission trackers, and regulatory archives.Partner ... Extedo, or equivalent).Strong knowledge of FDA, EMA, and ICH electronic submission standards and guidance.Excellent organizational skills, attention to detail,… more
- Insmed Incorporated (NJ)
- …Vault, and other similar software platformsKnowledge of 21 CFR Part 11, Electronic Records and Electronic SignaturesExperience with GAMP 5 guidelines and ... validation lifecycle processesIT System Project managementExperience managing vendor relationships for multiple software platformsWhere You'll WorkThis is a hybrid role based out of our Bridgewater NJ HQ office. You'll have the option to work remotely most of… more
- Merck & Co. (Rahway, NJ)
- …compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence Collaborate with publishing, registration, and planning ... teams to maintain alignment across the regulatory lifecycle. Electronic and Paper Archive Management Oversee the central archive team, including offshore contractors… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects.- Positions may ... of inspection results and maintain accurate records of findings in an electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch… more
- ALPCO (CA)
- …and documentation. Contribute to technical manuals, troubleshooting guides, and electronic reference resources. Apply strong analytical skills to resolve complex ... 5-10 years of experience diagnosing and repairing electromechanical or electronic laboratory equipment. Prior applications, field applications scientist (FAS), or… more
- Cipla (Fall River, MA)
- …SDS, FS, validation plan, FAT, SAT, IQ, OQ,PQ, validation certificate, PIR,RTM, electronic signature, electronic reports. Knowledge of 21 CFR and implementation. ... Knowledge of automation of pharmaceutical equipment. Education and Experience Associate's degree with 4-6 years knowledge and experience of GMP documentation required. Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, ... the assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.Utilizes tools within… more
- Merck & Co. (North Wales, PA)
- …CDER inspection planning, etc.Responsible for continuous improvement of the company's electronic submission process and providing tools and templates to support ... or vaccine regulatory application submission including the development of electronic submission deliverables.Experience with submission standards CDISC (SDTM, ADaM),… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to learn and be proficient in eLIMs, S4HANA (SAP) , MES (Manufacturing Electronic Batch Record), and a Learning Management System. Electronic Batch Record), and ... a Learning Management System.Strong interpersonal skills and the ability to work well in a team environment is a must.Language: English#Li-Onsite#Li-DD1The anticipated base pay range is$66,063—$86,706 USDBenefitsWe are committed to creating a workplace where… more
- Merck & Co. (North Wales, PA)
- …application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols ... and projects, directing the program development effort of other programmers; experience as a programming mentorAbility and interest to work across cultures and geographiesAbility to complete statistical programming deliverables through the use of global… more
- Aequor (Vacaville, CA)
- …(CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good ... documentation procedures (GDPs), review documentation as appropriate 20% Attain qualification for all assigned tasks and maintain individual training plan 10% Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc. 10%… more
- Merck & Co. (Durham, NC)
- …a Good Manufacturing Practice (GMP)-regulated manufacturing environment- Experience using electronic manufacturing systems (eg PAS-X, SAP, Delta-V, etc.)- Experience ... interacting with regulatory auditors as part of area tours and/or topic discussion- Lean Six Sigma certification- #MSJR VETJOBS Required Skills: Adaptability, Adaptability, Aseptic Manufacturing, cGMP Compliance, Data Analysis, Employee Performance Standards,… more
