Field Quality Assurance Specialist
3 weeks ago
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
- 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
- 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
No requirements for lifting or driving equipment
No exposure to hazardous materials
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