QC IT Application Analyst -#26-25264

Us Tech Solutions; Lexington (MA); On-site; USD 90,000 - 120,000; Part time

Job summary

US Tech Solutions is seeking a QC IT Application Analyst to support MA Biologics Operations, focusing on Quality, Validation and Product Development. This role involves project support, SDLC documentation, validation activities, and front-line triage. Requires 5+ years IT/business experience and GxP exposure in pharma or life sciences.

The candidate will manage multiple projects, oversee vendor solutions, and coordinate repair activities when systems are down, on a 6+ month onsite contract basis.

Qualifications

• More than 5 years IT/business experience with analysis and documenting requirements.
• Experience with software application implementations in a GxP environment.
• Experience in Pharmaceuticals or Life Sciences industry (preferred).
• Experience consulting or working in a complex global matrix organization (preferred).

Responsibilities

• Upgrades from Windows 7 to Windows 10.
• Provide oversight of vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners.
• Work with Direct team members for decisions and clarifications.
• Balance multiple projects and allocate billing time as needed.
• Design testing to support SDLC documents (SDLC, URS, FRA, Admin SOP, IQ, IOQ, ATR, data flow diagrams).
• Must have GXP experience with lab equipment.

Skills

ServiceNow

Veeva

TrackWise

Active Directory

NTFS permissions

Firewall rules

My Access

Communication skills

Education

Bachelor's degree in IT/CS/engineering/business

Tools

Windows Server

SQL Databases

Citrix

LDAP

Group Policy

TCP/IP Networks

Server Virtualization

RDP

Backup and Restore

MS Office 365

MS Visio

MS Project

Job description

Duration: 6+ Month contract with potential to extend Schedule: 5 days a week ONSITE. 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.
• 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).

Responsibilities:

• 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 decisions, 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 possess GXP experience with lab equipment.

Experience:

• 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).
• Experience in the Pharmaceuticals or Life Sciences industry (preferred).
• Experience consulting or working in a complex, global matrix organization (preferred).

Skillsets:

• Service now, Veeva, Trackwise, Active Directory, firewall rules, My Access, NTFS permissions.
• Excellent written and verbal communication.
• Applications impacted by upgrades, Ideal candidate should have previous experience implementing, and or upgrading. Other application experience can be considered.
• IT Technology Skills & Competencies.
• IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments.
• Familiarity with Automation systems such as SCADAs, PLCs, DCS, Client, 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.

Education:

• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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