QC IT Application Analyst

4 weeks ago

Lexington, United States Randstad Digital Full time
job summary:

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

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

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)




location: Lexington, Massachusetts

job type: Contract

salary: $77.09 - 87.09 per hour

work hours: 8am to 5pm

education: No Degree Required

responsibilities:


  • 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 -




  • TrackWise - CAPA, Deviation, Change Control
  • Veeva - Document Workflows
  • Familiarity with Operational Excellence and/or Continuous Improvement processes
  • Knowledge and familiarity of following Tools and technologies
  • MS Office 365, MS Visio, MS Project
  • Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP,
  • Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
  • Architectures - 2 Tier, 3 Tier, On-premise, Cloud


qualifications:

  • Experience level: Experienced
  • Minimum 5 years of experience
  • Education: No Degree Required


skills: UNIXSQL


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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