at APN Software Services Inc. in Newark, Delaware, United States
The QE will be responsible for validations and change projects in the Diagnostics quality control environment:
• Validations will include and not limited to: software, equipment and test methods.
• Types of changes will include and not limited to: documentation, work instruction, qualification, failure mode analysis, process and design.
o 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.
o The focus of the documentation is in the areas of, and not limited to: validation, spreadsheet and software, medical technology, testing procedure, process and datasheet, chemistry, bio/protein chemistry & purification, biology, bio processing.
o 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,
• Will work with a team on project plans, create or change documents, estimate timeline, and use various tools.
The position is planned for a 12-month period. Business needs may require additional periods.
Functions and responsibilities include:
Operations Quality Processes
• Learn and follow the Quality Change Process required in the Quality Control and Operations area.
• Develops, recommends and implements technical documentation changes to meet regulatory quality requirements and SAP based manufacturing system needs.
• Knowledge of FDA regulated environment and ISO/IVDD standards.
• Familiar with GMP, GLP and GDP processes.
• Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.
• Strong communication and interpersonal skills.
• Must be able to work independently and on a team and be able to multi-task and prioritize daily work.
• Identifies problems as they occur and takes appropriate steps to solve them.
• Flexibility to work overtime and/or irregular work hours as needed.
• Formatting, writing and editing of very complex technical documentation
• Plan, author, document, and execute projects.
• Strong computer skills in the knowledge of Microsoft Excel and Word, and macros.
• Strong understanding of information system validation.
• Enters data into internal computer systems and generates documents as required.
• Understands manufacturing related testing and processes for Diagnostic Analyzers.
• Understands Quality Control, Testing, Chemistry and Biology as pertains to the Diagnostics industry.
• Background in production processes relative to chemical and physical chemistry, concentration calculations and statistics.
• Familiar with basic laboratory techniques used in medical technology or chemistry lab.
Desirable experiences: validation, test methods and /or process with experience in the various phases of validations, testing equipment.
- 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 Engineering background.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.