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Type: Contract

Category: Scientific & Clinical

Job ID: 139910

Date Posted: 04/17/2019


Title: QA Associate

Location: Devens, MA

Schedule: 8am to 5pm Mon – Fri.

Responsibilities:

  • 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.
  • Provides QC support including lab inspections, method qualification, method technology transfer, LIMS and Smart Lab support, etc.

 

Requirements:

  • B.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

 

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


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