12-month contract to start with
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.
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.
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.
- Ideal candidate will have a B.S. or equivalent degree with 2-7 year experience in a relevant field with basic Medical Technologist, Chemistry/Biochemistry or Computer Science background
Thanks and Regards,
Imran (EMU) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-4704 Fax 510-623-5055
Imran@apninc.com (Google Hangouts)