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QA Associate

Job Post Index 20802A-Sy##
Location Devens, MA
Description: 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.
  • 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
Skills: Qualifications
  • Experience in SAP is required.
  • 5 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
  • Knowledge of US and EU cGMP regulations and guidance.
Preferred Qualifications
  • Knowledge of SAP, LIMS, Trackwise, Smartlab
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing
  • Experience in disposition
  • B.S., in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent

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