Job Details

  • Title:
    QA Associate
  • Code:
    RCI-BMS-26751-1
  • Location:
    Devens Massachusetts (MA) 01434
  • Posted Date:
    04/15/2019
  • Duration:
    6 Months
  • Status:
    Open/Slot Over
Recruiter Contact Detail

  Job Description

  • Maintains shop floor quality presence; releases raw materials, in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews.
  • Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines.
  • May assist in preparing for a hosting of regulatory and customer audits.
  • Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
  • Samples, inspects and releases consumable and raw materials per specifications.
  • Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
  • Drafts and reviews specifications and SOPs.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing.
  • Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
  • May provide guidance to less experienced staff.
  • Provides QC support including lab inspections, method qualification, method technology transfer, LIMS and Smart Lab support, etc.

Requirements:

  • S., in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent is preferred.
  • 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is preferred.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of SAP, LIMS, Trackwise, Smartlab are a plus