QC Laboratory Systems Analyst - GxP​/CSV W2 - BB

Job Description

QC Laboratory Systems Analyst – GxP / CSV– 100% On Site – W2 Only – BB10346

12 Month contract with potential to extend

Onsite Expectations:
5 days a week ONSITE.

Lexington, MA

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, GE
Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche
Light Cycler 480, File Maker Pro, Bartender, Charles River Endo Scan-V, GE
DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX,
Perkin Elmer Asset Genius, Thermo Web Admin for Tru Scan RM Analyzer, and
various Laboratory desktop applications used in GxP environment

· Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS,
Historians

· Experience with Computerized Systems Validation (CSV), 21 CFR Part 11
regulations, and Data Integrity compliance

· Experience working with ITIL processes in Service Now such as Incident
Management, Change Management, Problem Management, Asset and
Configuration Management (CMDB)

· Familiarity with following tools and processes –
o Track Wise – CAPA, Deviation, Change Control
o Veeva – Document Workflows

· Familiarity with Operational…