Randstad Quality Assurance in Cambridge, Massachusetts
salary:$32.40 - $38.10 per hour
date posted:Wednesday, October 11, 2017
Job Title: Quality Control Analyst I
Loc: Boston, MA
Function: CMC- GMP Test Management and Controls
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.
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.
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
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance