Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Validation Analyst (Laboratory)

Expired Job

Icon New York , NY 10007

Posted 4 months ago

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This position will entail all responsibilities surrounding the performance of analytical validations within ICON Laboratory Services including but not limited to the review of assay product inserts, preparation of validation plans, identification and attainment of suitable samples for validation studies, the performance of validation experiments, analysis and quality control of data and the preparation of validation reports.

Overview of the Role

  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Prepare accuracy, precision, correlation, or stability samples for validation studies.*

  • Assist in the preparation of validation plans and reports and in performance of results analysis.

  • Distribute and/or ship validation, correlation, or stability samples within or to ILS owned facilities and/or collaborators.*

  • Assist in coordinating the performance and completion of validation studies in a timely manner.*

  • Import data as needed into a statistical analysis tool such as EP evaluator or equivalent.*

  • Maintain a readily accessible, up to date electronic library of completed validation, correlation, or stability study statistical experiments.

  • Be available to assist laboratory in assay validation experiments as necessary.*

  • Perform other relevant tasks depending on the needs of the global validation department.*

  • Responsible for the performance of required manual procedures and operation of automated instrumentation under supervision of the Manager or Laboratory Director as necessary.

Education Requirements / Skills / Experience Required

  • Experience in assay validation in a clinical laboratory setting

  • Bachelors Degree in Medical Technology, Biomedical or equivalent science

  • Successfully manage multiple tasks and timeline

  • Liaise professionally with team members and system users

  • Perform assigned tasks with minimal supervision

  • Strong verbal and written communication skill

Benefits

Working for ICON you will be provided with an excellent benefits package.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.

What's Next

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Validation Analyst II

Icon

Posted 7 days ago

VIEW JOBS 1/10/2019 12:00:00 AM 2019-04-10T00:00 Validation Analyst II This is an excitingopportunity to work within a fast paced, busy environment for a leading globalprovider of outsourced development services to the pharmaceutical,biotechnology and medical device industries. This person will be providingtesting/validation support specializing in test script writing, execution, anddocumentation. Overview of the Role * Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. * As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. * Travel (approximately 2%) domestic and/or international * *Conduct testing activities according to relevant ICON Standard operating procedures (SOP's) and appropriate regulations. * *Write and execute formal test scripts and complete associated documentation and ensure test results are reported accurately. * Complete test script writing and execution for moderate to complex systems. * Authors and reviews key validation deliverables such as Validation Plan, Validation Summary Report, Traceability Matrices. * Function as testing lead for assigned projects including, but not limited to, planning the test effort and write test scripts ensuring system performs as intended. * Assess system for 21 CFR Part 11 Compliance and associated documentation. * Assist lead/manager and/or project team in client audits and/or regulatory inspections for queries related to Laboratory IT Systems. * *Communicate with lead/manager and/or project team regarding system testing progress and issues. * Complete assigned tasks within timeline constraints and report any quality issues to lead or manager in a timely manner. * *Liaise with technical project manager in the testing and implementation of systems. * Other responsibilities may be assigned as required. Role Requirements * To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * US/LATAM/CAN: minimum 4 years of experience in software testing/validation in a regulated environment. * EU/APAC: Prior proven experience in software testing/validation in a regulated environment. * Successfully manage multiple tasks and timelines. * Liaise professionally with team members and system users. * Basic understanding of SQL and database concepts. * Knowledge and hands-on experience in Test Automation Tools or Application Lifecycle Management (ALM). * Prior proven experience in testing application in Water Fall or Agile /Scrum development process. * Prior proven experience in all aspects of Software Validation Life Cycle (SVLC) such as Validation Plan preparation, Test Script preparation, Test execution, Defect reporting and tracking, Traceability Matrix preparation, Validation Summary Report preparation. * Prior proven experience in Black Box Testing, Graphical User Interface (GUI) Testing, User Acceptance Testing, Database Testing, System, Functional, Smoke, Sanity, and Regression Testing. * Prior proven experience in testing various applications developed in Java, .Net, Oracle, MySQL and C . * Experience in performing 21 CFR Part 11 Assessment for applications to ensure compliance to the regulation. * Experience and participation in audits from clients and/or inspections from regulatory bodies. * Knowledge of regulatory guidelines and regulations such as GCP, GLP, 21 CFR Part 11, Annex 11 etc. * Knowledge and hands-on experience with validation of mobile applications in a regulated environment. * Perform assigned tasks with little or no supervision. * Strong verbal and written communication skills * Bachelor's degree, or local equivalent, in information systems, science, or related discipline or relevant experience. * An alternative combination of experience, education and training determined by management to be equivalent to the foregoing. Benefits of Workingin ICON Other than workingwith a great team of smart and energetic people, we also offer a verycompetitive benefits package. This varies from country to country so adedicated recruiter will discuss this with you at interview stage. We care about ourpeople as they are the key to our success. We provide an open and friendly workenvironment where we empower people and provide them with opportunities todevelop their long term career. What's Next? Following yourapplication you will be contacted by one of our dedicated recruiters and ifsuccessful we will be able to provide you with more details about thisopportunity. ICON is an equalopportunity employer - M/F/D/V and committed to providing a workplace free ofany discrimination or harassment. ICON is an equalopportunity employer - Minorities/Females/Disabled/Veterans and committed toproviding a workplace free of any discrimination or harassment. Icon New York NY

Validation Analyst (Laboratory)

Expired Job

Icon