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ONSITE ROLE: QC Lab Systems Consultant

The Fountain Group LLC

Lexington, MA

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JOB DETAILS
SALARY
$85–$93 Per Hour
SKILLS
Analysis Skills, Asset Management, Automation Systems, Bartending, Billing, Biology, Biomedicine, Biotech and Pharmaceutical, Business Administration, Change Control, Change Management, Client Server Architecture, Cloud Computing, Code of Federal Regulations, Computer Science, Computer Workstations, Configuration Management, Consulting, Corrective and Preventative Action (CAPA) Systems, Customer Support/Service, Data Quality, Data Recovery, Desktop PC, Disability Insurance, Distributed Control Systems (DCS), Filemaker Database, GMP (Good Manufacturing Practices), GxP, ITIL (IT Infrastructure Library), Incident Management, Information Technology & Information Systems, Laboratory Systems, Life Insurance, Manufacturing Analysis, Manufacturing Systems, Microsoft Windows System Administration, Multitasking, Operational Support, Product Development, Product Testing, Programmable Logic Controller (PLC), Quality Control, ServiceNow, Software Design, Software Development Lifecycle (SDLC), Software Patches, Standard Operating Procedures (SOP), System Validation, Systems Analysis, Team Player, Test Design, Testing, Unicorn Library Management System, Work From Home, Writing Skills
LOCATION
Lexington, MA
POSTED
30+ days ago
Pay: $85-93/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance. 
Onsite role in Lexington, MA; possible remote work at manager’s discretion after fully up to speed
W2 Candidates only
Overall:
  • We are looking for a candidate who can support QCIT operations in a GMP environment.
  • Will be 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 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.
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
  • 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 TrackWise (CAPA, Deviation, Change Control) and Veeva for Document Workflows
  • 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
  • Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration
  • Experience in the Pharmaceuticals or Life Sciences industry

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
3407 W Martin Luther King Jr. Dr. Tampa, FL 33607
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/