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:
IT Technology Skills & Competencies
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
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)
- 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.
- 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
- 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)
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)
- 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
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
Numbers & Facts
| Location | Lexington, MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Skills
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