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Quality Assurance Specialist
Job Group: Research
Job Subgroup: Client-Based Research Services
Salary Range (Annual):
18: $39,400-80,520 Employee Category: Academic Staff
Job Code: RE008
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Job Summary:
Functions as a biomedical quality assurance team/project lead in various inspection and auditing capacities. Supervises training and documentation upkeep to ensure compliance with client and regulatory requirements and provide support to bio manufacturing projects.
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Job Responsibilities:
- Prepares, organizes, generates, and reviews cGMP documentation, Standard Operating Procedures (SOPs), quality control (QC) test procedures, and manufacturing process batch records
- Performs internal and external materials supplier and contract laboratory audits and responds to audit requests to ensure compliance with regulatory and technical requirements
- Inspects and releases incoming raw materials to ensure quality standards and regulatory requirements are met
- Reviews and approves equipment calibration and preventive maintenance records to ensure optimal and safe operation
- Creates and updates training materials and monitors staff compliance with established requirements
- Serves as a main point of contact with clients, provides project information, and updates and maintains a portion of a project-specific budget
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Education:
Bachelor's Degree Preferred Minimum
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FLSA Status:
Exempt
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Institution Job:
No
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Required Supervisory Duty of at Least 2.0 Full-Time Equivalent (FTE) Employees:
No
- Employee Category:
Academic Staff
- Scaled Job:
No
- Salary Range (Annual):
18: $39,400-80,520
- Job Code:
RE008: Quality Assurance Specialist
- Link directly to this job title: https://hr.wisc.edu/standard-job-descriptions/?q=RE008