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Quality Control Technical Consultant

Katalyst Healthcares & Life Sciences -
Lexington, MA

Quick Apply

Job Details

Qualifications

Requirements specification
Requirements design
Pharmaceutical regulatory compliance
Software implementation
FDA 21 CFR Part 11
GMP
Cleanroom protocols
Personal protective equipment (PPE) adherence
Laboratory compliance
LDAP
Software documentation
Sterile attire donning
Cleanroom experience
Analysis (software development lifecycle)
IT department experience

Full Job Description

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)

Quick Apply

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