- Legend Biotech USA, Inc. (Raritan, NJ)
- …with Quality systems (Change control, investigations, LIMs, etc.).Extensive technical writing experience.Knowledge in cell therapy validation ... in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Eisai, Inc (Baltimore, MD)
- …quality/attention to detail.Strong written and verbal communication skill required.Experience in writing deviations and/or strong technical writing ... AIEisai Salary Transparency Language:The base salary range for the Associate, Technical Operations is from :67,700-88,800Under current guidelines, this position is… more
- Merck & Co. (Rahway, NJ)
- …Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions, Technical Writing , Technology TransferPreferred Skills: Current ... Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline… more
- Merck & Co. (Rahway, NJ)
- …including development of standard work, investigations, and problem solvingStrong technical writing and project management capabilities.Understanding of new ... Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance,… more
- AUROBINDO (Durham, NC)
- …procedures and quality standards. Qualifications - Skills & RequirementsExcellent technical writing skills, communication skills, organization skills.Must be ... facility requirements. This individual will be responsible for:Leading, conducting, writing , reviewing and approving investigations for Deviations and Market… more
- ValSource, Inc. (Worcester, MA)
- …Matter Experts (SMEs) for critical design decisions. Demonstrate strong organization, technical writing and communication skills. Coordinate succinctly and ... phases from Concept Design, through Detailed Design and Execution. Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA,… more
- ValSource, Inc. (Rahway, NJ)
- …FMEA, HAZOP and Fault Tree Analysis desired. Strong leadership, verbal communication, technical writing , project management tools and word processing skills. ... (PQ). Troubleshoot and resolve issues that arise during validation activities, providing technical expertise and guidance. Ensure all validation work is performed in… more
- Merck & Co. (Durham, NC)
- …in a matrix organization and collaborate across functions Knowledge of cGMPs, technical writing , and data analysis Strong interpersonal, inclusive, and ... 5+ years (less experience considered if advanced degree) in Technical , Quality, Procurement, Manufacturing Operations, or related fields involving products… more
- Cipla (Hauppauge, NY)
- …skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply relevant scientific ... analyze all data, write final reports and obtain approvals. Review technical documentation such as batch records, SOPs, calibration records, preventive maintenance… more
- Merck & Co. (Durham, NC)
- …management) Experience working in a clean room or GMP/regulated manufacturing environment Technical writing experience Experience with PLCs, HMIs and other ... Root Cause Analysis (RCA), SAP PP (Production Planning), SAP Systems, Technical Problem-Solving {+ 5 more}Preferred Skills: Current Employees apply HERE Current… more
- Insmed Incorporated (NJ)
- …Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and approving ... validation plans, requirements, testing documents and summary reports.Familiarity with cloud-based systems and SaaS validationStrong customer service skills for internal and external customers and comfortable working in cross functional teams.Ability to… more
- Insmed Incorporated (San Diego, CA)
- …Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and approving ... validation plans, requirements, testing documents and summary reports.Familiarity with cloud-based systems and SaaS validationExperience managing oversight of multiple enterprise projects and processes at one time.Experience in evaluating and validating AI… more
- Insmed Incorporated (NJ)
- …Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.Strong technical writing skills for authoring, reviewing and approving validation plans, ... requirements, testing documents and summary reports.Experience with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of data integrity (ALCOA+)… more
- Cipla (Central Islip, NY)
- …skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply relevant scientific ... Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements,. Technical Knowledge and Computer Systems Skills Understanding of laboratory… more
- Cipla (Fall River, MA)
- …skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply relevant scientific ... Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines… more
- Merck & Co. (North Wales, PA)
- …success in the assurance of deliverable quality and process compliance.Excellence in technical writing and ability to convert complex ideas and information ... into simple readable form.Solid project management skills.Familiarity with clinical data management concepts.Strategic thinking ability to turn strategy into tactical activities, and ability to anticipate stakeholder requirements.Must also possess effective… more
- Cipla (Central Islip, NY)
- …Ability to take independent decisions for disposition of investigations. Ability to have technical writing skills related to QMS documents. Knowledge of Good ... Manufacturing Practices and Good Documentation Practices. Working knowledge in operation area. Ability to work effectively in a cross-functional team environment. Self-motivated, with the ability to work independently. Excellent organizational and analytical… more
- Cipla (Central Islip, NY)
- …and work under tight schedules and deadlines. Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles ... and practices. Must communicate clearly and concisely across levels, both orally and in written. Strong command over written and verbal English is required. Physical Requirements Should not have any restriction to work with powder containing active… more
- Aequor (Thousand Oaks, CA)
- …Operational Excellence tools, six sigma, FMEA Experience in TMS (eg SAP TM) and BW Experience setting up service level agreements Good technical writing skills ... OPEN MARKET RATE REMOTE Contract Length: 3 years No relocation Will need to be onsite for carrier visits or internal meetings Ideal candidates will have a minimum of 5 years of experience in logistics or transportation, with a strong preference for those who… more
- Merck & Co. (Rahway, NJ)
- …deliver results, while balancing multiple priorities simultaneously- Proven ability to communicate technical findings clearly in writing and presentations to a ... Organic Chemistry, Process Chemistry, Programming Languages, Scientific Research, Scientific Writing , Statistical AnalysisPreferred Skills:Current Employees apply HERE Current Contingent… more
