Job Details

  • Title: Project Coordinator
  • Code: RCI-19764-1/19756-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 10/16/2020
  • Duration: 6 Months
Talk to our Recruiter

  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 include the following:

  • Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
  • Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols, reports, manufacturing batch records, and laboratory information system (LIMS)
  • Used to processes and procedures (SOPs) in a cGMP environment
  • Highly preferred Technology Transfer background with biologics manufacturing
  • Must have Pharma industry experience
  • Provide sample label generation support and coordination of label placement in the manufacturing batch records.
  • Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports.
  • Periodic check-in with laboratories and sample requestor on the receipt of samples
  • 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
  • Maintain and enforce sample management workflow and processes
  • Daily coordination with manufacturing to confirm that sampling plan and sampling requirements are understood and followed, where required
  • Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and sample plan changes
  • Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign. This can involve responsibility for campaign closure activities.
  • LIMS experience (LIMS experience is not mandatory, but strongly preferred)
  • Bachelor degreeĀ In science field or related discipline preferred
  • An associate degree can be consider
  • Understanding concept of large scale biologics manufacturing
  • Self-managed
  • Strong technical writing skills a must