Quality Assurance Quality Control (QA-QC) Inspector II

Position Title: Quality Assurance Quality Control (QA-QC) Inspector II

Work Location: Worcester, MA 01604

Assignment Duration: 6 months (possible extension-performance based)

Work Schedule: Sunday-Thursday, 2pm-10:30pm

Position Summary: The Associate Data Reviewer supports the data review team within a fast paced GMP environment in support of one or more of the following areas; raw material, environmental monitoring, in-process, final bulk, stability or validation. The coordinator will complete review of assays, data mining projects, and archiving of data. Works under the guidance of a supervisor but is able to manage time efficiently in achieving timely completion of assigned duties

Background & Context: Supports the data review team within a fast-paced GMP biopharmaceutical manufacturing environment at The Organization.

Key Responsibilities:

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  Archiving of data in the RIMS system

  
  
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  Performs Routine Review of Lab test data including On-the-Floor Review, and Off-the-Floor Review for low complexity test methods.

  
  
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  Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements

  
  
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  Understand, implements and maintains GMP with respect to laboratory records, procedures and systems in accordance with procedural requirements

  
  
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  Accepts responsibility to complete assigned tasks as committed. Works with other to maintain a positive atmosphere to accomplish business objectives

  
  
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  Supports the review team with administrative tasks such as logbook management and scanning/filing of data.

  
  
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  Participates in training of other employees, but focused on demonstration and not management of training delivery

  
  

Qualification & Experience:

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  Bachelor's Degree OR High School Diploma with 5+ years of combined experience in manufacturing, QA, QC in pharmaceutical or biologics industry

  
  
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  organizational skills

  
  
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  time management

  
  
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  bachelors degree or equivalent

  
  
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  experience with RIMS, Empower, A280