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Quality Control Lab Data & Infrastructure Support

  1. North America, East Coast
Ohio
  1. Contract
Competitive
  1. Life Sciences
38030
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Quality Control Lab Data & Infrastructure Support - US, Ohio - 12-18 Month Contract

This is a fantastic opportunity for a Quality Control Lab Data & Infrastructure Support  to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
The scope includes creation, management, tracking, compilation, and review of various data and metadata, including:
  • Sample Test Requests for Third Party Testing
  • Sample Results, COAs, COTs, Stability Analyses Reports
  • QC Data Trending Reports, QC Data and Testing Progress Trackers
  • QC/Sample Deviation Tracking
  • Sample Shipment Management (shipping requests, shipment tracking)
  • ELN Templates
  • ELN and LIMS Master Data (equipment, consumables, reagents, reference standards, etc.)
  • ELN Template Creation/Review/Approval Timeline Management
  • ELN and LIMS Master Data Verification (SPV of Master Data Entry)
  • Standard Operating Procedures (SOPs) for performing the above activities
  • Support two distinct QC work areas: internal and external manufacturing.
  • Work alongside LP2 QC SME’s and supplement the SME work on QC data management
  • Author, manage, and track QC data
  • Provide hands-on support for meeting attendance of oversight of external manufacturing
Skills and Experience:
  • Previous experience working in QC laboratories and managing QC data.
  • Substantial experience with pharmaceutical manufacturing and GMP-compliant systems.
  • Strong attention to detail and data integrity focus.
  • Previous experience with ATMP or specifically Gene Therapy manufacturing or QC
  • Previous experience with ELN or LIMS systems
If this role is of interest, please apply now!
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