Field Quality Assurance Specialist
21 hours ago
This role is 100% Onsite
Job SummaryThe 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
- High School Degree required
- Relevant college or university degree preferred
- Minimum 4 years' relevant work experience, with experience in a Quality Assurance role
- 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
No requirements for lifting or driving equipment
No exposure to hazardous materials
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