Job Details

  • Title: Project Coordinator
  • Code: RCI-PFE-14829-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 05/06/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

looking for QC lab or analytical background. looking for someone with project coordinator experience, manage timelines and manage schedules. Sample handle, some tech writing.   collect the lab results and validate info(where lab background/knowledge comes in)

Job Description:

The primary focus of this position is to provide sample management and associated logistical support during a drug substance process validation campaign.

Key responsibilities:

  • Create and maintain a master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
  • Maintain and enforce sample management workflow and processes
  • Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols and batch records, and laboratory information system (LIMS)
  • Support ad-hoc, supplemental sample requests utilizing a paper-based or electronic sample request workflow; coordinate with sample requestor and manufacturing on ad-hoc/supplemental sample requests
  • Daily coordination with manufacturing to confirm that the sampling plan and sampling requirements are understood and followed, where required
  • Periodic check-in with laboratories and sample requestor on the receipt of samples
  • Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and sample plan changes
  • Query and collate laboratory results from submitted samples; provide the data verification and documentation support to summarize laboratory results in validation and technical reports.
  • Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign
  • Provide sample label generation support and coordination of label placement in the manufacturing batch records.

 

Skills:

  • Must have Pharma industry experience
  • analytical background
  • analyst in a lab
  • LIMS experience (LIMS experience is not mandatory, but strongly preferred.)
  • understanding concept, attention to detail
  • Self-managed
  • follow processes and procedures
  • SOP, CGMP environment