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Randstad Senior Project Coordinator in Andover, Massachusetts

Senior Project Coordinator

job details:

  • location:Andover, MA

  • salary:$40 - $50 per hour

  • date posted:Friday, October 16, 2020

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:804042

job description

Senior Project Coordinator

job summary:

Great client is looking for a contractor for a 6 month Project Coordinator role.

location: Andover, Massachusetts

job type: Contract

salary: $40 - 50 per hour

work hours: 9am to 5pm

education: Bachelors

responsibilities:

  • 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, 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 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.

qualifications:

  • Must have Pharma industry experience

  • LIMS experience (LIMS experience is not mandatory, but 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

skills:

  • LIMS, Pharma, process validation, project coordination

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