Quality Assurance - Sample Management and Labels
Keywords Studios•Indianapolis, IN
•Onsite
About The Position
Quality Assurance provides quality oversight of the sample management and labeling of clinical trial materials. The role is responsible for ensuring compliance with all applicable GMPs, GDPs, internal standards, procedures for sample management and labels activities PRD. Mix of desk-based administrative tasks and warehouse-based activities.
Requirements
- Bachelors’ Degree/Associate Degree with previous work experience.
- Basic computer skills including Microsoft Office, TW, QDoc, SAP, and web-based applications
- Previous warehouse experience
- Willingness/ability to work in a chilled environment (5 deg C)
- Standing, lifting (up to 50 lbs.), and bending are required
- Ability to work off hours and weekends
- Must be able to pass background check and drug screen.
Responsibilities
- Provide Quality verification of documentation related to receipt, inspection and retention of samples (Retention sample, Reference sample, Rib samples, etc.).
- Coordinate samples receive and inspection with other functional area (API, DP, vTeam, etc.)
- Provide Quality verification of samples data and document in SAP.
- Support with annual RIB sample inspection
- Process samples for destruction
- Review and approval of Labels
- Review procedures, tools and provide feedback for process improvement
- Initiation, complete and QA oversight of ICI’s, Change controls and deviations
- Perform other duties as required.
Benefits
- Medical, dental and vision benefits
- Paid time off (including sick and select holidays)
- 401(k) enrollment with 3% employer matching
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
