QC IT Application Analyst

Lancesoft; Lexington (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft seeks a QC IT Application Analyst to collaborate with business and IT teams, supporting GMP operations and validation activities. The role involves overseeing SDLC documentation, user access reviews, and audit trails, while managing multiple projects with limited supervision.

Ideal candidates have 5+ years in IT/business within a regulated environment, a relevant degree, and experience with tools like ServiceNow, TrackWise, and Veeva.

Qualifications

• More than 5 years relevant IT/business experience in GxP environment is required.
• Bachelor's degree or equivalent in IT/science/engineering or business administration is required.
• Experience in Pharmaceuticals or Life Sciences is preferred.

Responsibilities

• Provide project support for MA Biologics Operations Site Functions Quality, Validation and Product Development.
• Manage work with limited oversight; upgrade projects from Windows 7 to Windows 10.
• Handle ad-hoc technical requests from internal and external partners.

Skills

IT experience

SDLC documentation

GxP knowledge

Active Directory

NTFS permissions

SQL databases

LDAP

Windows Server

Citrix

Veeva

TrackWise

ServiceNow

21 CFR 11

Education

Bachelor's degree in IT/CS/Engineering

Tools

ServiceNow

TrackWise

Veeva

Citrix

MS Office

Job description

Onsite Expectations

5 days a week ONSITE Description: 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 descisions, 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, 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, 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

Physical Demands

Must be able to lift, push, pull and carry up to 30 lbs. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

Must be able to work in controlled environments requiring special gowning. Will potentially be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tabaco, candy etc. May be used in the QC / Manufacturing environment. During onboarding and training Onsite requirement will be 5 days per week. Afterwards minimum 3-4 days a week onsite is required. Must be able to work overtime as required. May be required to work in a confined area