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Post-Market Quality Complaints
2 months ago
Job Title: Specialist Quality Complaints – Remote
Duration: 6 Months Project with Possible extension
Terms: Contract W2
Pay Range: $40/hr to $45/hr W2 All Inclusive
.
Description:
Under general direction, functions as the Chromatography Data System (CDS) Business Administrator, working at the Biochemistry QC HPLC laboratory. Implement CDS related improvements, including but not limited to development, validation, troubleshooting, documentation, change control and system administration in compliance and regulatory standards.. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
SKILLS:
* Strong experience in Quality of Complaint Records, Trend Investigations
* Reviewing & acknowledging information contained in Product Complaint records.
* Extensive knowledge and application of GMPs/CFRs
* Ability to evaluate and document Compliance issues as per guidelines
* Assign appropriate Investigation requirements
* Status update on Return Samples
* Facilitate cross-functional meetings to plan & coordinate the plan for closure of records
* Data analysis and trend evaluation assessments
EDUCATION:
* master’s degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 8-9 years of experience OR High school diploma/GED and 10-12 years of experience
Preferred Qualifications
Major in Chemistry with approved Computer Sciences courses
Must have Strong knowledge as template builder in Empower, including development of custom fields calculations.
