Job Details

  • Title: QC Associate
  • Code: RCI-PFE-15064-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 05/15/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

The Andover QC Microbiology Building A/ Microbial ID group is looking for an individual to fill a QC Associate role that will be responsible for writing investigations generated within the QC Microbiology testing group in Andover. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. The QC Associate will also be responsible for review of microbiological laboratory data generated in support of commercial and clinical manufacturing.

Responsibilities:

The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. Investigation areas will include testing deviations, invalid or questionable result investigations, instrument calibration Out-of-Tolerance reports, and environmental monitoring excursions.

In addition to performing investigations, the individual will be responsible for reviewing cGMP testing data generated by the QC Microbiology testing group for completeness and accuracy.

Other areas of focus:

  • Lead continuous improvement projects
  • Revise standard operating procedures
  • Represent the QC Microbiology group when working with cross-functional teams
  • Assisting with instrument validations and other special projects
The incumbent must have the ability to interpret and document test results according to standard operating procedures using all standard Quality systems, experience using Microsoft Office applications and LabWare LIMS is desirable.

Requirements:
  • Must have excellent verbal and written communication skills
  • Experience with cGMP’s, SOP’s, Labware LIMS and TrackWise is preferred
  • Some rotational weekend and Holiday coverage may be required to support the commercial manufacturing schedule
  • Must be proficient with Microsoft Office Suite.
  • BS in Microbiology or related field with 2-4 years of industry experience, preferably in the biopharmaceutical industry is required