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System One Services QA Associate I in Marlborough, Massachusetts

QA Associate IMarlborough, MA

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:158082

Date Posted:11/12/2020

Title:QA Associate

Location:Marlborough, MA

Schedule:Mon-Fri; 7am-3:45pm

Type:Direct Hire

Start date:ASAP

Responsibilities:

  • 95% of the job will be performing batch record review; to include review of production records, quality control records such as (i.e.: monthly RO/DI, weekly Environmental Monitoring records), and weekly/monthly logs

  • Bind and file completed batch records and other administrative activities

  • Identification of process deviations

  • Identification of Out-of-Specifications (OOS) results

  • Label Verification

Requirements:

  • AS/BS in Science2 years’ experience in a QA role in an ISO 9001 certified Quality Management System or equivalent environment

  • Strong experience with Batch Record Reviews

  • Must be familiar with Factory Acceptance Test (FAT)

  • Must have knowledge of ASME BPE codes and requirements

  • Must be familiar with GMP/ non-GMP systems used by pharmaceuticals

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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