QC IT Application Analyst

USDM Life Sciences; Lexington (MA); Remote; USD 96,000 - 110,000; Full time

Job summary

USDM Life Sciences is seeking a QC IT Application Analyst to support GMP QC IT operations, including validation activities, access reviews, and audit trail reviews. You will also provide front-line client support and oversee vendor solutions in a Windows environment, using Veeva, TrackWise, and ServiceNow.

The role requires a Bachelor’s degree in Computer Science or Information Systems, familiarity with CSV and 21 CFR Part 11, and experience in ITIL processes.

Qualifications

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

Responsibilities

• Collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
• Provide oversight of vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners in accordance with projects assigned.
• Work with Direct team members for decisions and clarifications as needed.
• Must be able to juggle multiple projects and split billing time between projects where needed.
• Experience with design testing of applications to help author SDLC documents.

Skills

Veeva

TrackWise

ServiceNow

Windows

Word

Excel

Education

Bachelor's degree in Computer Science or Information Systems

Tools

MS Office 365

MS Visio

MS Project

Citrix

SQL Databases

LDAP

Group Policy

TCP/IP Networks

Server Virtualization

RDP

Backup and Restore

Job description

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

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.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 70.00 - 80.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.