Randstad Quality Assurance in Cambridge, Massachusetts

Quality Assurance

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job details:

  • location:Cambridge, MA

  • salary:$32.40 - $38.10 per hour

  • date posted:Wednesday, October 11, 2017

  • job type:Contract

  • reference:22878

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description

Job Title: Quality Control Analyst I

Loc: Boston, MA

Function: CMC- GMP Test Management and Controls

Position Description

  • Documentation support

  • Assess temperature excursions and issue memos to support product use

  • Conduct reference standard (RS) performance monitoring (Data entry, trending, make trend charts)

  • Interpret data with support from supervisor, and contribute to technical reports and regulatory filings

  • Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems

  • Download data from offsite test labs and organize in QC servers

  • Build study/tests and enter GMP data in validated data repositoryVendor Management Support

  • Track and request vendor quotes, manage invoice approvals

  • Manage external reference standard storage site and support RS inventory management

  • Coordinate test sample shipments from manufacturing to testing sites

  • Work with department peers to execute well defined assignments.

Position Responsibilities

  • Candidate must be detail-oriented, possess excellent oral and written communications skills and knowledge of cGMP is a must.

  • Must be able to work well independently as well as participate in teams comprised of immediate and/or cross-functional members.

  • Experience with Microsoft Word, Excel, PowerPoint is a must.

  • Experience with QUMAS, Citrix is a plus.

Position Requirements

  • LINE FUNCTION SPECIFIC QUALIFICATIONS:Biologics - Analytical Development, Cell Culture, Process Development, Formulations

  • Associates degree in Chemistry, Biology or equivalent with 2+ years relevant industry experience or Bachelor degree in Chemistry, Biology or equivalent with relevant industry experience

  • Previous experience with cGMP required, experience in Quality Control and/or Analytical Development preferred

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance