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Freezerworks System Analyst

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Gaithersburg, Maryland
Start date
Nov 3, 2021

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We are currently searching for a Freezerworks System Analyst to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Gaithersburg, MD.

Duties & Responsibilities
  • Implement and oversee the updating and development of the Freezerworks system from the existing Labware LIMS system
  • Lead the program data warehousing initiative to ensure smooth transmission of data to regulatory organizations, partner CROs, and partner pharmaceutical companies.
  • Liaise closely with QA personnel to ensure data and sample chain of custody integrity in accordance with GLP.
  • Assist in preparation for GCLP inspections and outside quality audits.
  • Create QC criteria and protocols regarding data quality and standardization working with the QA personnel.
  • Guide junior staff in the day-to-day use of the LIMs and barcoding systems for implementation purposes.
  • Design, implement, and manage data streams from study proposal, through all assay and general lab procedures, to analysis and reporting in compliance with data integrity best practices and FDA title 21 part 11.
  • Manage data formatting input and output with other sample processing and data manger staff.
  • Write SOPs for data workflows and procedures, work with QA personnel to validate.
  • Represent lab when needing to present data handling capabilities both internally or externally and work with prospective clients to implement new data streams.
  • Implement and maintain data processing scripts to transform data for upload and export to repositories and/or monitor/improve existing procedures.
  • Implement and maintain reports for various data management systems.
  • Train lab staff on data workflow and procedures as well as best practices for data handling and formatting.
  • Support lab management with data processing needs such as exclusions or all data sets for reporting.
  • Develop workflows for extraction of data directly from the analytical equipment.
  • Support statisticians with data processing needs to provide them with data in required structure for statistical analysis with a variety of tools (e.g., SAS).
  • Maintain LIMS systems; Monitor the system, ensure LIMS is always operational, assist with upgrades, write necessary SOPs for maintenance and preventative maintenance (with QA sign off).
  • Assist with new application interfacing such as Electronic Laboratory Notebook (ELN), maintenance and training, third party system integration etc.
  • Maintain, monitor, and improve where necessary internal structures, permissions, and users as needed by lab staff working in conjunction with IT.
  • Respond to issues experienced by lab staff and work in conjunction with IT to resolve.
  • Liaise with clinical, laboratory, QA and IT staff on all aspects relating to the LIMS system if required.
  • Train staff on LIMS systems use; Write SOPS for LIMS system use.
  • Handle ordering and create cost projections on LIMS systems installation and annual maintenance.
  • Provide IT technician specifications of installation and management vendor travel and training
  • Work with QA and IT on performance testing and validation of systems.
  • Liaise with vendors on new systems and feature development.
  • Perform basic and continuing training for Labware LIMS version 7.

 

Requirements
  • Bachelor’s degree in Information Technology, Computer Science, or a related discipline.
  • Minimum of seven (7) years of experience in a computer related field.
  • Demonstrated experience with various computer systems and software packages.
  • Strong computer system expertise, from a super-user rather than an IT perspective.
  • Lab information management systems experience – LabWare LIMS desirable.
  • Demonstrate ability to multi-task and prioritize projects efficiently, as well as ability to work independently and proactively on various projects.
  • Demonstrate attention to detail, with strong troubleshooting and problem-solving skill.
  • Knowledge of governing regulations.
  • Excellent technical writing skills and good documentation practices with understanding of standard operating procedures.
  • Demonstrate ability to work in a team setting and to handle high-through put environment.
  • Ideally possess the ability to speak the language of laboratory, clinic, QA, and IT personnel.
  • Strong oral and written communication skills both technical and interpersonal

#LI-EJ1

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

 

 

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

 

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth. 

 

What you’ll get…

  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.

 

 

 

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.

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