Field Quality Assurance Specialist

21 hours ago


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

This role is 100% Onsite

Job Summary

The Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with Client policies, standards, procedures, and Global cGMP.

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
Requirements
  • High School Degree required
  • Relevant college or university degree preferred
  • Minimum 4 years' relevant work experience, with experience in a Quality Assurance role
Qualifications
  • Equivalent combination of education and experience acceptable
  • 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
  • Sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
Additional Information

No requirements for lifting or driving equipment

No exposure to hazardous materials



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