Quality Assurance Specialist II

US-MA-Bedford
1 week ago(12/7/2017 8:44 AM)
Job ID
2017-1034
# of Openings
1
Category
Quality

Overview

Works with other departments to ensure the quality of products and compliance to internal procedures and external standards. Reviews records from production and testing and records for product development. Reviews, develops, and improves quality system procedures, specifications, and test methods.  Provides oversight for elements of the quality system such as change control or deviations. May support investigations of quality issues or perform quality audits.

Responsibilities

  • Maintain and continuously improve quality system processes and procedures
  • Review documentation supporting GMP activities for accuracy and completeness
  • Participate on project teams as the QA representative
  • Release Batch Records and labeling for manufacturing
  • Review executed Batch Records and associated test results
  • Coordinate or perform investigations of quality issues and product complaints and implement corrective/preventive actions
  • Review change controls and validation documentation
  • Assist with internal audits and supplier audits as needed
  • Monitor performance of quality systems and generate reports to communicate status to management
  • Perform other quality assurance duties as assigned

Qualifications

  • Bachelor’s degree in relevant scientific discipline
  • Minimum three years of experience in pharmaceutical, biotech or medical device industry
  • Excellent organizational skills and attention to detail
  • Good verbal and written communication skills
  • Strong interpersonal skills and ability to work efficiently on a team
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
  • Ability to make decisions and resolve issues with minimal guidance
  • Knowledge of FDA and international regulations and GxP guidelines

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