IT Lab Systems Analyst GMP and CSV and Validation

Job Description

Job DescriptionJob Title : IT Lab Systems Analyst GMP/CSV/Validation
Location : Hybrid, Lexington, MA
Visa : No H1B/TN
Duration : 12 Month contract with very good potential to extend
Interview : Video

LinkedIn with pic
Photo ID
(2-3) references from Past managers with COMPANY email and contact
This Is A " Lab Systems Analyst!!!
Must Be Able To Write Test Scripts
Knowledge Of " Iq, Oq, (Validation)
Perform System, Instrument & Sw Upgrades
Previous Exp Upgrading Qc Systems!!
**** Gmp Is a Must!! ***
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 clarifications 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, Track wise, 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

IT Technology Skills & Competencies:
IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments;
Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bio profile CDV and Flex2, Roche Cedex, Roche Light Cycler 480, FileMaker Pro, Bartender, Charles River Endo Scan-V, GE DataPro2, Informa it Inform/CC, Lonza Win KQCL, Mettler Toledo Lab X, 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.