Quality Assurance Inspector

  • location: Framingham, MA
  • type: Contract
  • salary: $29.27 - $34.44 per hour
easy apply

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
  • 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.
  • 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.

easy apply

get jobs in your inbox.

sign up

related jobs