Demo

QC IT Application Analyst

TechData Service Company
Lexington, MA Temporary
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/22/2025

Job Description

Job Description

QC IT Application Analyst – BB9155

BB9155

Lexington, MA

12 Months

12 Month contract with potential to extend

Onsite Expectations :

For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.

Job Description :

The QC IT Application Analyst collaborates with the business and IT teams to provide

project support for MA Biologics Operations Site Functions – Quality, Validation and

Product Development.

The QC IT Application Analyst manages their work with limited oversight-

The scope of work includes, but is not limited to the following :

  • Project upgrades from win 7- win 10
  • Provide oversight of vendor-provided solutions
  • Handle ad-hoc technical requests from both internal and external partners in

accordance with projects that are assigned.

  • Work with other Direct team members for descions, and clariffications as needed
  • Must be able to juggle multiple projects and deliverables, and split billing time
  • between projects where needed.

  • Experience with performing design testing of application to help author SDLC
  • documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application

    Data Flow diagrams, etc.

  • Must poses GXP experience with lab equipment.
  • Recommended Experience

  • Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access,
  • NTFS permissions. Excellent written and verbal communication.

    Applications impacted by upgrades, Idele candidate should have previous experience

    implementing, and or upgrading. Other application experience can be considered.

  • Vaya Raman
  • 7500 Fast PCR
  • Hiac Particle Counters
  • Maldi-tof
  • Vi-Cell Cell counter
  • Antaris II
  • Waters Andrew Alliance
  • Education and Experience Requirements

    More than 5 years relevant IT / business experience, analysis, and documentation

    of business and technical requirements (required)

  • Experience with software application implementations in GxP environment
  • required)

  • Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration,
  • Experience in the Pharmaceuticals or Life Sciences industry (preferred)
  • Experience consulting or working in a complex, global matrix organization
  • preferred)

  • Knowledge of Lean operational techniques (preferred)
  • Key Skills, Abilities, and Competencies

    IT Technology Skills & Competencies

  • IT Experience deploying and supporting Quality and Manufacturing Systems
  • including Analytical Instruments – Empower, Chromeleon, SOLO VPE, GE

    Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche

    LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE

    DataPro2, Informait InForm / CC, Lonza WinKQCL, Mettler Toledo LabX,

    PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and

    various Laboratory desktop applications used in GxP environment

  • Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS,
  • Historians

  • Experience with Computerized Systems Validation (CSV), 21 CFR Part 11
  • regulations, and Data Integrity compliance

  • Experience working with ITIL processes in ServiceNow such as Incident
  • Management, Change Management, Problem Management, Asset and

    Configuration Management (CMDB)

  • Familiarity with following tools and processes –
  • o TrackWise – CAPA, Deviation, Change Control

    o Veeva – Document Workflows

  • Familiarity with Operational Excellence and / or Continuous Improvement
  • processes

  • Knowledge and familiarity of following Tools and technologies
  • o MS Office 365, MS Visio, MS Project

    o Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP,

    Group Policy, TCP / IP Networks, Server Virtualization, RDP, Backup and

    Restore

    o Architectures – 2 Tier, 3 Tier, On-premise, Cloud

    Physical Demands :

  • Must be able to lift, push, pull and carry up to 30 lbs.
  • In general, the position requires a combination of sedentary work and walking
  • around observing conditions in the facility.

    Working Environment :

  • Must be able to work in controlled environments requiring special gowning. Will
  • potentially be required to follow gowning requirements and wear protective

    clothing over the head, face, hands, feet and body.

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any
  • oral food, tabaco, candy etc. may be used in the QC / Manufacturing environment.

  • During onboarding and training Onsite requirement will be 5 days per week.
  • Afterwards minimum 3-4 days a week onsite is required.

  • Must be able to work overtime as required.
  • May be required to work in a confined area
  • TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

    Company Description

    www.techdataservice.com

    Company Description

    www.techdataservice.com

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