Quality Engineer
Newark, DE
12-month contract to start with
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.
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.
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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 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)
linkedin.com/in/imranshikalgar