The Role
Establishes and maintains quality assurance programs, procedures, and controls. Tracks quality complaints and detractors, identifies trends, prepares statistical summaries, supports product review and release, develops database solutions, writes procedures, assists with GMP audits, and reports findings to management and cross-functional teams.
Summary Generated by Built In
We are seeking a QA Complaints Analyst to establish and maintain quality assurance programs, procedures, and controls while ensuring that product performance and quality system elements are continuously measured to support improvement initiatives.
Duties & Responsibilities:
- Monitors and tracks all sources of quality detractors utilizing the service database and complaint database.
- Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.
- Develops solutions to database problems of moderate scope and complexity.
- Writes and assists others in writing standard operating procedures.
- Generates and identifies significant trends.
- Regularly reports them to management and appropriate cross functional teams.
- Provides advanced technical assistance in the use of information mapping technology.
- Provides support to product review and release functions.
- Generates moderately complex statistical summaries.
- Provides support to good manufacturing practice auditing.
Requirements
- Bachelor’s degree or equivalent (related field).
- 2–4 years of related professional experience.
- Experience with quality investigations and complaint handling is highly preferred.
- Bilingual proficiency in English and Spanish.
- Must be available to work all shifts.
Skills Required
- Bachelor's degree or equivalent in a related field
- 2-4 years of related professional experience
- Experience with quality investigations and complaint handling
- Bilingual proficiency in English and Spanish
- Availability to work all shifts
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
