QC IT Application Analyst Position Available In Middlesex, Massachusetts

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 possess 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. Vaya Raman 7500 Fast PCR Hiac Particle Counters Maldi-tof Vi-Cell Cell counter Antaris II Waters Andrew + Alliance Education & Qualifications 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) Bachelors 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 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•o TrackWise•CAPA, Deviation, Change Control o Veeva•Document Workflows Familiarity with Operational Excellence and/or Continuous Improvement processes • Knowledge and familiarity of following Tools and technologies o MS Office 365, MS Visio, MS Project o Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore o Architectures•2 Tier,