QC IT Application Analyst, Lexington, MA, US

QC IT Application Analyst

Overall:

• 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)

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.
• 7500 Fast PCR
• Vi-Cell Cell counter
• Antaris II

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 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
• Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore

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.