USA - Technical Consultant

Job Title: QC IT Application Analyst (JR)

ID: 26-05005

Location: Lexington, MA 02421

Duration: 12-month contract with potential to extend

Position Type: Onsite

NOTE: During onboarding and training, the onsite requirement will be 5 days per week.

Afterwards, a minimum of 3-4 days a week onsite is required

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 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 Windows 7 to Windows 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

• ServiceNow, 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 and Experience Requirements

• More than 5 years of relevant IT/business experience, analysis, and documentation
• of business and technical requirements (required)
• Experience with software application implementations in a 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 Technology Skills & Competencies

• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments - Empower, Chromeleon, SOLO VPE, Client Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, Client 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, clients, 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 the following tools and processes -

• TrackWise - CAPA, Deviation, Change Control
• Veeva - Document Workflows
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity with the 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-premises, Cloud

Contact:

Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com