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Project Coordinator

Job Post Index 22534E-Sy##
Location Andover, MA
Description: Job Description
  • Provide sample management and associated logistical support during a drug substance process validation campaign.
  • Create and maintain 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, reports, manufacturing 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 sampling plan and sampling requirements are understood and followed
  • 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 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. This can involve responsibility for campaign closure activities.
  • Provide sample label generation support and coordination of label placement in the manufacturing batch records.
Skills: Qualifications
  • Bachelor's Degree in science field or related discipline preferred.
  • Great communication skills.
  • Technology Transfer background with biologics manufacturing.
  • Pharma industry experience.
  • LIMS experience strongly preferred.
  • Understanding concept of large scale biologics manufacturing.
  • Attention to detail.
  • Self managed.
  • Used to processes and procedures (SOPs) in a cGMP environment.
  • Strong technical writing skills a must .

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