QC IT Application Analyst

United Pharma; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking a QC IT Application Analyst to support GMP-compliant operations, including validation activities, backup/restore testing, and audit trail reviews. You will collaborate with Quality, Validation and IT teams on QA systems and participate in SDLC documentation.

Responsibilities include front-line client support, handling ad-hoc IT requests, and oversight of vendor-provided solutions while ensuring data integrity and adherence to 21 CFR Part 11.

Qualifications

• Bachelor’s degree in Computer Science or Information Systems or related field if preferred.
• Experience with CSV, 21 CFR Part 11, and Data Integrity compliance.
• Familiarity with ITIL processes in ServiceNow (Incident, Change, Problem, CMDB).
• Knowledge of SDLC documentation such as URS, FRA, IQ, IQOQ, SOPs, and data flow diagrams.

Responsibilities

• 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.
• Project upgrades from Windows 7 to Windows 10; oversight of vendor-provided solutions; handle ad-hoc technical requests; coordinate repair activities when systems are down.
• Assist with design testing of applications and author SDLC documents; maintain documentation revisions and process improvement.

Job description

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)

Primary Responsibilities

• 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 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 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.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• Systems & Tools: Experience with Veeva, TrackWise, and ServiceNow is preferred. The team operates in a Windows environment, and strong proficiency in Word and Excel is essential for document revisions, updates, and design work.
• 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

Education & Certifications

Bachelor’s degree in Computer Science or Information Systems or related field if preferred.