Quality Control Technical Consultant

Katalyst CRO; Lexington (MA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

The QC IT Application Analyst at Katalyst CRO collaborates with business and IT teams to provide compliance-focused support for GMP environments, including validation activities, incident triage, and system upgrades.

You will manage SDLC documentation (URS, IQ/OQ/ATRs), perform design testing, and oversee vendor-provided solutions while ensuring data integrity and regulatory compliance across Quality and Manufacturing systems.

Qualifications

• More than 5 years relevant IT/business experience, analysis, and documentation.
• 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).

Responsabilités

• Project upgrades from Windows 7 to Windows 10.
• Provide oversight of vendor-provided solutions.
• Handle ad-hoc technical requests from internal and external partners.
• Work with Direct team members for decisions and clarifications as needed.
• Must juggle multiple projects and deliverables across projects.

Connaissances

GxP IT systems support

CSV, 21 CFR Part 11

ITIL processes (ServiceNow)

Vendor oversight

SDLC documentation

Backup and Restore testing

Cross-functional collaboration

Formation

Bachelor's degree in IT/CS/Engineering

Outils

Empower

Chromeleon

SOLO VPE

Client Unicorn

Nova Bioprofile CDV

WinKQCL

LabX

TrackWise

Description du poste

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)

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 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 application to help author SDLC
• documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Flow diagrams, etc.
• Must poses GXP experience with lab equipment.

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 egulations, 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

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)