QE Technical Writer Specialist with QE or Medtech

Hello Taryn,
Hope you are doing well!
 
I came across your resume on Job board and am reaching out to you because I feel you might be a great match for a “QE Technical Writer Specialist”  opening that I am looking to fill for my client in “Newark, DE, 19702”. “This position is with a  high growth company”  the project duration is for approximately 12+ months with a “High possibility of extension”, I would appreciate a few moments of your time to go over the job description and see if this position might be a mutual fit
 
General Description: 
The QE will be responsible for change projects, technical documents, and software: 
·         Types of changes will include and not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software and process validations. 
·         Work will include: gathering of any necessary information, drafting, editing, coordinating information and needs with various area leads and managers, and implementing complex technical testing or production processes, and change documentations. 
·         The focus of the documentation is in the areas of, and not limited to: spreadsheet and software, medical technology, analytical testing, chemistry, bio/protein chemistry & purification, biology, bio processing, organics, and physical chemistry of solids. 
·         These tests and procedures impact all current diagnostics platforms at the site. The efforts are categorized into projects leading to quality improvements and production systems implementation. 
 
Specialist aspects: 
The incumbent will be involved with multiple projects from a change project perspective. Tasks will vary and involve: 
• Understanding the Quality Control processes 
• learning the change process used at the site, 
• following these procedures, 
• create project plans, 
• create various types of documents, 
• estimate timeline, 
• use necessary tools and resources to complete the projects per plan. 
 
Time frame: 
The position is planned for a 12-month period. Business needs may additional periods. 
 
Functions and responsibilities include: 
- Learn the Quality Change Process required in the Quality Control and Operations area. 
- Follow the Quality Change Process to implement various changes categorized by projects. 
- Plan, author, document, and execute the projects. 
- Formatting, writing and editing of very complex technical documentation 
- Develops, recommends and implements technical documentation changes to meet regulatory quality requirements and SAP based manufacturing system needs. 
- Strong background with documented evidence of having worked in technical writing at the industry level. 
- Understand the basics of Quality Control, Testing, Chemistry and Biology. 
- Knowledge of FDA regulated environment. 
- Familiar with GMP, GLP and GDP processes. 
- Knowledge or familiarity with SAP production system. 
- Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools. 
- Background in production processes relative to chemical and physical chemistry 
- Familiar with basic laboratory techniques used in medical technology or chemistry lab. 
- Strong computer skills in the knowledge of Microsoft Word and Excel, and macros. 
- Strong communication and interpersonal skills. 
- Must be able to work independently and be able to multi-task and prioritize daily work. 
- Identifies problems as they occur and takes appropriate steps to solve them. 
- The incumbent must have hands-on experience in medical technology, validations, position is focused on equipment, test methods and /or process validations, with experience in the various phases of validations: 
o Protocol initiation 
o Gaining protocol approval 
o Support execution 
o Authoring all documents including the final report. 
 
Education: 
- Ideal candidate will have a B.S. or equivalent degree with 1-5 year experience in a relevant field with basic Medical Technologist, Chemistry/Biochemistry or Computer Science background.
 
Regards
 
Ronny Dsouza
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560
ronny@apninc.com
Phone: 510-870-8707

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