QC IT Application Analyst

Steneral Consulting; Lexington (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

None

Job summary

Steneral Consulting seeks a QC IT Application Analyst to support GMP environments in Lexington, MA. The role focuses on validation activities, user access reviews, and patching of GxP workstations while coordinating repair actions when systems fail.

Candidate will manage SDLC-related documentation and collaborate with IT and business teams on upgrades, vendor oversight, and ad-hoc requests. A bachelor’s degree and 5+ years of IT/GxP experience are preferred.

Qualifications

• Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.
• Experience with software application implementations in GxP environment is required.
• More than 5 years relevant IT/business experience, analysis, and documentation.

Responsibilities

• 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 and decommissioning activities (final backups and account deactivations).

Skills

GxP experience

CSV

ITIL processes

SQL basics

Documentation

Education

Bachelor's degree in IT/CS/Engineering

Tools

ServiceNow

Veeva

TrackWise

Active Directory

SQL Databases

Job description

DURATION: (1) year with extension !

LOCATION: Lexington, MA- Need locals

DURATION: (1) year with extension !

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).

• Supporting decommissioning activities (for example, final backups and account deactivations)
• 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

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.

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 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 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

• 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