QC IT Application Analyst - Randstad USA

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

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