Quality Assurance Inspector

  • location: Framingham, MA
  • type: Contract
  • salary: $29.27 - $34.44 per hour
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job description

Quality Assurance Inspector

job summary:
  • Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation.
  • Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements.
 
location: Framingham, Massachusetts
job type: Contract
salary: $29.27 - 34.44 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Conducts internal audits of manufacturing processes to ensure compliance.
  • Conducts review of testing results.
  • Reviews document and completes inspection of returned goods.
  • May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.
  • Interprets complex, explicit documentation to ensure quality standards and compliance.
  • May provide training to new employees.
  • Works under only very general supervision.
  • Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Contributes to the completion of organizational projects and goals.
  • Represents organization on specific projects.
 
qualifications:
  • Bachelor's Degree in a scientific field and 4-6 years experience in a Quality and /or other cGMP related field, or Master's Degree in a scientific field and 2 years' experience in above.
  • 2 years of experience in a Quality role.
  • Technical writing, SOP Design, GMP expertise, experience/familiarity with biologics manufacturing operations
  • Knowledge in external agency regulations (FDA, EMA, etc.) ? Strong computer, verbal and written communication skills.
  • Experience in quality systems.
  • Experience in leading cross functional team.
  • Experience with Trackwise or equivalent system.
Preferred Qualifications

  • 3+ years experience in a Quality Assurance role.
  • Experience in bio-pharmaceutical industry.
  • Capable of analyzing trends and metrics that lead to improvement.
  • Strong technical writing skills.
  • Effective time management, attention to detail, organizational skills, teamwork and collaboration.
  • Significant capability in problem solving methodology.
  • Experience working in an environment of operational excellence.
  • Experience training and developing employees.
  • Experience participating in external agency inspections.
  • Knowledge of regulatory enforcement trends.
 
skills: SOP, FDA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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