QC Laboratory Systems Analyst GxP CSV W2

Job Description

QC Laboratory Systems Analyst – GxP / CSV– 100% On Site – W2 Only – BB10346

12 Month contract with potential to extend

Onsite Expectations: 5 days a week ONSITE.

Lexington, MA

• We are looking for a candidate who can support QCIT operations in a GMP environment, including:
• Developing and executing periodic validation activities (backup and restore testing, user access reviews, and audit trail reviews)
• Front-line client support and triage (initial assessment and coordination of repair activities when systems are down)
• Supporting GxP workstation patching activities
• Supporting decommissioning activities (for example, final backups and account deactivations)

• 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.

• 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

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)

• 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 Light Cycler 480, File Maker Pro, Bartender, Charles River Endo Scan-V, GE DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, Perkin Elmer Asset Genius, Thermo Web Admin for Tru Scan 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 Service Now such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
• Familiarity with following tools and processes –
• Track Wise – CAPA, Deviation, Change Control
• Veeva – Document Workflows
• Familiarity with Operational Excellence and/or Continuous…