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Quality Assurance Analyst
Deerfield, IL
Job Description
The job role description includes the product complaint intake, close-out, and reconciliation for commercial products.
Essential Duties and Responsibilities:
- Maintain awareness of regulatory requirements for product complaint
handling.
- Understand the Vault QMS solution and ensure continued learning.
- Assist in preparation and review of product complaints through the eQMS and other departmental documents.
- Duties include effectively perform quality analysis across multiple products and projects-including high volume tasks.
- Conduct a reconciliation of the product complaint reports received
from the call center.
- Support and document sound product complaints, regulatory decisions and justifications.
- Compile complaint metrics as requested for submission andManagement Review Meetings.
- Monitor, track and process of product
complaint intake forms documentation.
- Conduct a reconciliation of the product complaint reports received
from call center vs. product complaints.
- Maintain regulatory files in a format consistent with requirements.
- Assist with the process ofthe PC report for review and approval using the eQMS as required.
handling.
- Understand the Vault QMS solution and ensure continued learning.
- Assist in preparation and review of product complaints through the eQMS and other departmental documents.
- Duties include effectively perform quality analysis across multiple products and projects-including high volume tasks.
- Conduct a reconciliation of the product complaint reports received
from the call center.
- Support and document sound product complaints, regulatory decisions and justifications.
- Compile complaint metrics as requested for submission andManagement Review Meetings.
- Monitor, track and process of product
complaint intake forms documentation.
- Conduct a reconciliation of the product complaint reports received
from call center vs. product complaints.
- Maintain regulatory files in a format consistent with requirements.
- Assist with the process ofthe PC report for review and approval using the eQMS as required.
This position is a part time position
The number of hours per week will vary but will not exceed 20 hours
per week.
per week.
This individual may be remote to perform these tasks but must work during the standard
office hours of 8:00am to 4:30pm Central Time.
office hours of 8:00am to 4:30pm Central Time.
Requirements
Education:
- Bachelor's degree in a scientific discipline.
Requirements:
- Scientific & Regulation knowledge.
- Project management skills.
- Ability to multi task, prioritize projects and deadlines.
- Strong interpersonal and communication skills.
- Technical systems skills.
- Ability to identify compliance risks and escalate whenneeded.
- Must have experience with documentation practices per SOP QA-03, "Good Documentation
Practices".
Job Requirements:
Education: Bachelor's degree in a scientific discipline. Requirements: Scientific & Regulation knowledge. Project management skills. Ability to multi task, prioritize projects and deadlines. Strong interpersonal and communication skills. Technical systems skills. Ability to identify compliance risks and escalate whenneeded. Must have experience with documentation practices per SOP QA-03, "Good Documentation Practices".
Job Summary
Company
Automated Systems, Inc.
Start Date
As soon as possible
Employment Term and Type
Regular, Part Time
Required Education
Bachelor's Degree
Required Experience
Open
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