QC IT Application Analyst -#26-25264

$85-$92 per hour

Lexington, MA

Contract

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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