Job Description
Job Description Job Title: QC IT Application Analyst (JR)
ID: 26-05005
Location: Lexington, MA 02421
Duration: 12-month contract with potential to extend
Position Type: Onsite
NOTE: During onboarding and training, the onsite requirement will be 5 days per week.
Afterwards, a minimum of 3-4 days a week onsite is required
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 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 Windows 7 to Windows 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 possess GXP experience with lab equipment.
Recommended Experience
- ServiceNow, 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 of relevant IT/business experience, analysis, and documentation
- of business and technical requirements (required)
- Experience with software application implementations in a 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, clients, 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 the following tools and processes
- TrackWise CAPA, Deviation, Change Control
- Veeva Document Workflows
- Familiarity with Operational Excellence and/or Continuous Improvement processes
- Knowledge and familiarity with the 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-premises, Cloud
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com