APOLIS2024POSITION TITLE: QC IT Application Analyst
DURATION: 12 Month contract with potential to extend
LOCATION: Lexington, MA, USA 02421 (Hybrid role)
Pay Rate Range - $70.00-90.00/hour on W2.
Onsite Expectations:
For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.
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 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 assigned projects.
- Work with other 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 applications 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. Ideal candidate should have previous experience implementing or upgrading. Other application experience can be considered, such as:
- 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 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 of 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-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, tobacco, candy etc. may be used in the QC / Manufacturing environment. During onboarding and training, onsite requirement will be 5 days per week. Afterwards, a minimum of 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
