at Acara Solutions in Newark, Delaware, United States
Acara Solutions is looking for a Quality Engineer for our Client located in Newark, DE.
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.
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: validation, spreadsheet and software, medical technology, testing procedure, process and datasheet, chemistry, bio/protein chemistry & purification, biology, bio processing.
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.
Operations Quality Processes:
Learn and follow the Quality Change Process needed 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.
Identifies problems as they occur and takes appropriate steps to solve them
Formatting, writing and editing of very complex technical documentation
Plan, author, document, and execute projects.
Enters data into internal computer systems and generates documents as needed.
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.
Pay and Benefits:
The salary for this position is $ 41.00 per hour (Max Pay rate).
Required Skills / Qualifications:
Minimum of 2 years' experience with basic Medical Technologist or Chemistry/Biochemistry Engineering background
Preferred Skills / Qualifications:
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.
Good communication and interpersonal skills.
Good computer skills in the knowledge of Microsoft Excel and Word, and macros.
Good understanding of information system validation.
Familiar with basic laboratory techniques used in medical technology or chemistry lab.
Be able to work independently and on a team and be able to multi-task and prioritize daily work.
Experiences: validation, test methods and /or process with experience in the various phases of validations, testing equipment.
Upon offer of employment, the individual will be subject to a background check and a drug screen.
Flexibility to work overtime and irregular work hours as needed.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.