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QC Data Reviewer

Norwood, MA 02062

Posted: 07/25/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 544696 Is job remote?: No Country: United States

Job Description

Job Description The Role

In this role, you will support QC Labs with review of test records.

Heres What Youll Do
  • Review executed QC test records for product release and environmental monitoring.
  • Additional duties may be assigned

Heres What Youll Need (Minimum Qualifications)
  • BA or BS degree in Biology, Microbiology or similar field
  • 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
  • Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
  • Previous experience managing quality records such as change controls, deviations, and lab investigations

Heres What Youll Bring to the Table (Preferred Qualifications)
  • In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
  • Experience with rapid microbiological methods
  • Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment

Sunday-Wednesday Second Shift
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