Location: Lexington, MA
Salary: $60.00 USD Hourly - $90.00 USD Hourly
Description: Position SummaryWe are seeking a QC IT Application Analyst to support Quality Control IT (QCIT) operations within a GMP-regulated biopharmaceutical manufacturing environment. This individual will provide technical support for laboratory and quality systems, manage validation and compliance activities, support application lifecycle management, and partner with Quality, Validation, Product Development, and IT teams to ensure reliable and compliant operations.
The ideal candidate will have experience supporting GxP-regulated systems, laboratory instrumentation, computerized systems validation (CSV), and pharmaceutical manufacturing environments. This role requires strong technical troubleshooting skills, the ability to manage multiple projects simultaneously, and a commitment to maintaining compliance with regulatory and data integrity requirements.
Key ResponsibilitiesQC IT Operations & System Support- Execute periodic validation activities, including backup and restore testing, user access reviews, and audit trail reviews.
- Provide front-line technical support, troubleshooting, and triage for laboratory and quality systems.
- Coordinate repair and recovery efforts for business-critical systems and applications.
- Support GxP workstation patching, maintenance, and lifecycle management activities.
- Assist with application and system decommissioning activities, including final system backups, archival activities, and account deactivation.
Project Support & System Administration- Collaborate with business and IT stakeholders to support Quality, Validation, and Product Development initiatives.
- Support application and infrastructure upgrades, including operating system migrations and application modernization projects.
- Provide oversight and coordination of vendor-supported systems and services.
- Address technical requests from internal and external stakeholders related to assigned projects.
- Work closely with cross-functional teams to resolve issues, clarify requirements, and deliver project objectives.
- Manage multiple projects and competing priorities with minimal supervision.
Validation & Compliance- Perform application design testing and validation activities.
- Contribute to the creation and maintenance of SDLC and validation documentation, including:
- User Requirements Specifications (URS)
- Functional Risk Assessments (FRA)
- System Design and Configuration Specifications (SDCS)
- Installation Qualification (IQ)
- Operational Qualification (OQ/IOQ)
- Audit Trail Reviews (ATR)
- Administrative SOPs
- Application Data Flow Diagrams
- Ensure compliance with GxP requirements, Computerized Systems Validation (CSV) standards, 21 CFR Part 11 regulations, and data integrity practices.
Required Qualifications- Bachelor's degree in Information Technology, Computer Science, Engineering, Business Administration, or a related field, or equivalent experience.
- 5+ years of IT, business systems, or application support experience.
- Experience implementing, validating, and supporting software applications in GxP-regulated environments.
- Experience supporting laboratory systems, manufacturing systems, and analytical instrumentation.
- Strong technical troubleshooting and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently while managing multiple projects and priorities.
Preferred Qualifications- Experience within the pharmaceutical, biotechnology, or life sciences industry.
- Experience working within a global, matrixed organization.
- Knowledge of Lean Manufacturing, Operational Excellence, or Continuous Improvement methodologies.
- Experience supporting software and instrument upgrade initiatives.
Technical Skills & ExperienceEnterprise Applications & Systems- ServiceNow
- Veeva
- TrackWise
- Active Directory
- NTFS Permissions
- Firewall Management
- MyAccess/User Access Management
Validation & Quality Systems- Computerized Systems Validation (CSV)
- 21 CFR Part 11 Compliance
- Data Integrity Programs
- CAPA, Deviations, and Change Control Processes
Laboratory & Manufacturing SystemsExperience supporting and maintaining systems such as:
- 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
- Various GxP laboratory desktop applications
Laboratory Instrument ExperienceExperience supporting, implementing, validating, or upgrading the following systems is highly desirable:
- Vaya Raman
- Applied Biosystems 7500 Fast PCR
- HIAC Particle Counters
- MALDI-TOF
- Vi-Cell Cell Counter
- Antaris II
- Waters Andrew and Alliance Systems
Infrastructure & Technology- Microsoft Office 365
- Microsoft Visio
- Microsoft Project
- Citrix
- Windows Desktop and Windows Server
- SQL Databases
- LDAP
- Group Policy
- TCP/IP Networking
- Server Virtualization
- Remote Desktop (RDP)
- Backup and Restore Technologies
- Cloud and On-Premises Architectures
- Two-Tier and Three-Tier System Architectures
Automation SystemsFamiliarity with:
- SCADA Systems
- PLCs
- Distributed Control Systems (DCS)
- Building Automation Systems (BAS)
- Historians
ITIL ProcessesExperience with:
- Incident Management
- Change Management
- Problem Management
- Asset Management
- Configuration Management (CMDB)
Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.
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