Field Quality Assurance Specialist

3 weeks ago


Devens, Massachusetts, United States Surnise Systems Inc Full time
Job Title: Field Quality Assurance Specialist

This role is responsible for ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

Responsibilities:
  • Ensure manufacturing compliance with applicable procedures and batch records
  • Provide real-time review of manufacturing batch record documentation and logbooks
  • Work with operations to resolve manufacturing issues
  • Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
  • Routinely recognize and resolve Quality issues; Inform management of proposed solutions
Requirements:
  • High School Degree required
  • Relevant college or university degree preferred
  • Minimum 4 years' relevant work experience, with experience in a Quality Assurance role
Preferred Qualifications:
  • Equivalent combination of education and experience acceptable
  • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Understands continuous improvement and improves efficiency and productivity within the group or project
  • Builds relationships internally within and with cross-functional teams
  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
Additional Information:

No requirements for lifting or driving equipment

No exposure to hazardous materials



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