Quality Control

  • location: Cambridge, MA
  • type: Contract
  • salary: $35 - $37.39 per hour

job description

Quality Control

Job Title: Quality Control Analyst I

Position Responsibilities

  • 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 repository
  • Vendor 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 Requirements

  • Required:

    • 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
  • Knowledge and Skills:

    • 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.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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