Burlington, MA
Date Posted: November 07, 2016
Employment Type: Direct Hire
Job Id: 7245

Job Description

Sr. Quality Assurance Manager

General Responsibilities:

  1. Assist with the monitoring, managing and improvement of the quality system; ensures that the quality system meets regulatory compliance requirements.
  2. Manages the approved supplier list (ASL); assists in performing audits of key suppliers and contract laboratories, and performs trending of suppliers.
  3. Responsible for the development of and approval of quality control and inspection plans; review and approval of master batch records; and review and approval of validation protocols and reports.
  4. Responsible for the incoming inspection; in-process monitoring and inspection of the manufacturing process; review and approval of executed batch records; approval of final product disposition; and performs product trending
  5. Manages the investigation of product field issues to include complaints and returns; ensures proper documentation of complaint analysis and failure investigation; performs trending on product complaint and failure investigations. 

Skills and Abilities

  • Will possess a thorough knowledge of quality system requirements per cGMP, QSR and ISO, and the ability to audit per these requirements.
  • Should display sound judgment practices.
  • Must be proficient in complaint handling and reporting requirements. 
  • Ability to perform in a team environment as well as an individual contributor.
  • Strong written and oral communication abilities.
  • Must be able to visually inspect/examine products (and/or use appropriate measuring devices), components and written material.
  • Extensive interaction with all facility/company personnel (Manufacturing, R&D, Materials/Planning, Customer Service, HR).
  • Interaction with suppliers, customers, and sales representatives.


  • B. S. Science or Equivalent
  • Strong Background in Chemistry preferred
  • Minimum seven (7 ) years quality experience, preferably in the pharmaceutical industry.
  • Must have experience with cGMPs, QSR and ISO 13485 regulations.
  • Must have a thorough knowledge of quality system requirements.
  • Must have thorough knowledge batch record requirements.


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