at Acara Solutions in Newark, Delaware, United States
Acara Solutions is looking for Quality Engineer for our Client located in Newark, DE
The individual will be responsible for laboratory testing on instruments, troubleshooting and test process changes.
Perform test methods on various chemistry, analytical and diagnostic equipment.
Instrument Systems maintenance and Testing will include and not limited to: Dimension, Dimension Vista, Atellica, Stratus CS, Cobas.
Hard/software relative to LIMS and troubleshooting of laboratory systems.
Documentation, work instruction, qualification, validation, failure mode analysis, software and process validations.
The incumbent be involved with multiple projects from a change and troubleshooting project perspective.
Tasks will vary and involve, 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.
Completes manufacturing related testing and processes for Diagnostic equipment and analyzers.
Background in production processes relative to chemical and physical chemistry, concentration calculations and statistics.
Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.
Enters data into internal computer systems and generates documents as needed.
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.
Pay and Benefits:
The Salary for this position is $32.00 per hour (Max Pay rate).
Required Skills / Qualifications:
Minimum of 2 years' Experience with LIMS and information systems.
Minimum of 2 years' Experience in Chemistry/Biochemistry or Medical Technologist
Preferred Skills / Qualifications:
Experience in analytical chemistry, equipment maintenance, LIMS, test methods or process validations, medical technology.
Good knowledge of GLP and GDP as per clinical chemistry practices.
Knowledge of FDA regulated environment and ISO/IVDD standards.
Familiar with GMP, GLP and GDP processes.
Good communication and interpersonal skills.
Able to work independently on a team and be able to multi-task and prioritize daily work.
Knowledge or familiarity with SAP production system.
Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.
Good computer skills in the knowledge of Microsoft Word and Excel, and macros
Understanding the Quality Control processes
Understands Quality Control, Testing, Chemistry and Biology as pertains to the diagnostics industry.
Advia, Centaur, Immulite.
Upon offer of employment, the individual will be subject to a background check and a drug screen
Flexibility to work overtime or 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.