• JN -012020-4119
  • Illinois All, Illinois
  • 2020-01-17


Greetings from Saxon Global Inc.

 

We have an Immediate need for a Quality Assurance Analyst II with experience in Healthcare or Pharma domain. This is a 12+ Months Contract opportunity located in Lake Forest, IL 60045. Please review the job description below and contact me ASAP if you are interested.

 

Title: Quality Assurance Analyst II

Location: Lake Forest IL 60045

Duration: 12+ month Contract

 

Our Hiring Objective:

        This IT QA role will be assigned to our new LIMS, Laboratory Information Management System, which is an electronic system to track workflows, capture test results, route results for approvals and create the Certificate of Analysis. The system will help us with reporting and trending.

        We will be implementing Labware, a validated system, to ensure our laboratory operations are compliant.

        The QA will support the project by writing the validation plan, qualification protocols (IQ/OQ/PQ) and corresponding reports.

        They will also write test plans, perform data setup and support the business during testing.

        They will review the testing results and ensure Good Documentation Practices (GDP) have been followed.

 

POSITION SUMMARY:

        Individuals within the Quality Assurance (QA) role are responsible for ensuring that solution delivery meets all governance and user requirements. They are involved in all phases of the solution development lifecycle.

        They implement quality assurance objectives, standards and processes, monitor and evaluate project work products against predetermined objectives, and apply recommended actions for improvements. This role collaborates with project stakeholders (i.e. Project Management, Business Analysis, Development, Testing, Operations, Business, etc.) to ensure quality and delivery objectives of projects are met.

        They define and track quality assurance metrics such as BRD reviews, FRD reviews, code reviews, unit testing results, defects, defect counts, test results (SIT and UAT) and test status (unit, SIT and UAT). These professionals communicate solution quality results and provide recommendations based on issues discovered.

        They also monitor, evaluate and make recommendations on quality assurance tasks within enterprise wide processes such as PMO and change and release management. Members of this role need to have an understanding of software development life cycles, standards definition, process design, and a strong knowledge of quality management.

        They must be able to understand business requirements, technical specifications and change management documentation in order to audit work products against standards.

        In addition, they must be highly skilled communicators who can both provide training to delivery teams and clearly define where practice diverges from standards and recommended remediation.

        This associate will work on multiple projects as a quality lead, as well as projects that have system-wide impact and integrate across the organization. Will also perform troubleshooting for complex hardware, software or service problems.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

        Contributes solution quality and architecture.

        Leads teams to support solution quality strategies and activities.

        Reviews Test Plan information with team lead, as requested.

        Collaborates with project stakeholders to create a structured project test plan test template for all impacted/non-impacted functional and technical system components, assumptions, risks and entrance/acceptance criteria.

        Assists in leading risk assessment to determine need for validated testing.

        Prepares report of risks and mitigations and reviews these with project leadership

        Supports the prioritization of requirements and matches resources with requirements.

        Provides assistance to internal and external auditors in compliance reviews.

        Provides assistance to internal and external auditors in FDA compliance reviews.

        Evaluates quality of business requirements for medium to large projects based on Business/ Functional Requirement document(s), use cases and/or solution design documents.

        Participates in requirement/ design reviews; identifies gaps during reviews and probes for detailed explanation of expectations.

        Evaluates business efficiency and risk to make recommendations on application of testing standards.

        Reviews test scripts.

        Performs oversight and review of test execution, defect resolution and change control documents to verify standards are met.

        Evaluates test results against project standards and documents results of the review.

        Collaborates with Test Engineers and Business Analysts to remediate issues

        Provides training on testing policies, standards and tools both in informal one-on-one or formal classroom settings standards.

        Ensures completeness and accuracy of all documentation for assigned work products.

        Ensures that processes are followed.

        Evaluates business efficiencies and risks to make recommendations on application of testing standards.

        Supports and helps establish systems environment standards.

        Evaluates and makes recommendations on tasks within enterprise wide processes such as change and release management.

        Suggests and influences process improvements and acts as a change agent for the organization.

        Monitors and analyzes internal testing process metrics for continuous improvement.

        Provides mentoring to team members.

        Trains team members on various testing tools.

        Recommends training programs targeting specific areas of improvement.

        Evaluates future technologies and makes recommendations for service, software and hardware upgrades.

        Evaluates and recommends test automation tools and determines suitability with various development tools.

        May review and provide feedback on vendor proposals for new service, hardware and software.

        Supports and participates in the formal reporting of project status.

        Participates in lessons learned sessions with Project Managers.

 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

        Bachelor’s Degree in computer science, information systems, business administration, or other related field or equivalent work experience.

        Typically has 5-7 years of IT and business experience, with at least 4 years in Quality Assurance.

        Typically requires 3 or more years of audit or assessment or other relevant experience.

        More than 2 years’ experience with multiple software testing technologies.

        Strong knowledge and/or experience with the processes and concepts of testing regulatory compliance.

        Understanding with FDA regulations such as 21 CFR Part 11 and GxP.

        Knowledge of validation lifecycle and relevant pharmaceutical regulations.

 

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

        Ability to use manual and automated testing tools to support and assist the company testing efforts

        Demonstrated experience documenting and executing testing policies and standards

        Strong knowledge of relevant technology, tools and software; SDLC, Desktop services, TFS, HP Test tools, or equivalent testing tools.

        Knowledge of Quality Assurance responsibilities in a regulated environment, preferably healthcare

        Ability to communicate effectively both orally and in writing

        Strong analytical, problem-solving and conceptual skills

        Excellent organizational skills; attention to detail

        Ability to resolve project issues effectively and efficiently

        Ability to prioritize workload and consistently meet deadlines

 

*** What special requirements/skills you would like us to screen for (i.e.: "Must Haves")? ***

·        The candidate should have 3 years’ experience in writing validation test plans.

·        Needs to have experience implementing Laboratory Information Systems like Labware

·        LIMS experience is a must

·        Agile process would be a plus.

·        If the candidate has work history around Cloud solution implementation that would be a plus

 

Hemant Baidya

Saxon Global Inc.

p: (972.550.9346) ext: 302

d: 972.885.6690

a: 1320 Greenway Drive, Suite #660, Irving, TX

w: www.SaxonGlobal.com e: hemant@saxonglobal.com


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