Create technical narratives, instructions, procedures, or descriptions based on multiple source data.Compile and identify technical information from multiple sources.operator training, maintenance training and etc. Work on various training sessions, e.g. operator manual, running maintenance, heavy maintenance, IPC and etc. GMP or medical device: 3 years Location: One location.Work Schedule (Define days,# of hours)/ Is Overtime offered or required?ĭoes this position offer the ability to work remotely on a regular basis? Knowledge of TrackWise, SAP, Maximo systems.What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? In depth knowledge of Electronic Document Management Systems (Veeva a plus, others are acceptable).In depth knowledge of MS Word, including use of tables, headers/footers, and review capabilities (FS-Pro knowledge a plus).What are the top 3-5 skills requirements should this person have? 3-5 years’ experience in Technical Writing, in a GMP or medical device manufacturing environment.Previous experience in medical device, biotech industries or pharmaceutical.University Degree – BA/BS – Bioscience, Business, English or Education (preferred).Years of experience/education and/or certifications required: In depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.Īre you open to look at candidates willing to relocate?.BA/BS, Bioscience, Business, English or Education (preferred)Previous experience in pharmaceutical, medical device, or biotech industries3-5 years experience in Technical Writing in a GMP or medical device manufacturing environment.The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.JOB Qualifications (Minimum Requirements): Influences and negotiates with coworkers at to resolve NCRs and CAPAs.Gathers information, analyzes and determines best approach for complex production process changes.Maintains records on changes and provides reports to supervisor.Identifies areas for improvement within existing documentation and provides creative ways to make all documents better.including the appropriate verifications steps. Ensure that the information contained in procedures corresponds with the information on related documentation such as forms, inspection records, etc.Act as subject matter expert in document creation, format and alteration.Create new or revise existing content with a high degree of quality.Assist SMEs in creating first drafts from process maps, outlines, and direct observation.Ensure that technical information and parameters contained within operating procedures, work instructions and related forms match those parameters identified in associated validations and/or verifications.Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity.Participate in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality and other subject-matter experts to develop document content.Responsible for the execution of all steps to ensure timely completion of changes. Works with complex tasks and tight deadlines. Work under minimal supervision to author changes to production based controlled documentation, including but not limited to operating procedures, work instructions, batch records and forms.KEY Duties AND Responsibilities: Describe SCOPE: Works with Change Control, Quality Investigations /CAPA team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications. Establishes partnerships with Managers and supervisors in Production. The Senior Technical Writer is responsible for the development, creation, and revision of controlled documentation in accordance with client policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Length of Contract: 1 year (although I may want to start with a 3 month increment to confirm good fit)
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