QC IT Application Analyst
LanceSoft
Job Title: QC IT Application Analyst (JR)
Location: Lexington, MA 02421
Duration: 12 Month contract with potential to extend 5 days a week ONSITE Overall :
Job Description:
Recommended Experience
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Physical Demands:
Location: Lexington, MA 02421
Duration: 12 Month contract with potential to extend 5 days a week ONSITE 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 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 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
Vacancy posted 5 hours ago
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