Position Details
About this role
This role involves ensuring manufacturing quality and compliance through investigation of deviations, product impact analysis, CAPA implementation, and validation support within a GMP environment.
Key Responsibilities
- Investigate deviations
- Perform product impact analysis
- Manage CAPA processes
- Approve SOPs and calibration requests
- Support validation and quality improvement
Technical Overview
Focuses on manufacturing quality assurance, deviations, CAPA, validation, and GMP compliance, supporting process improvements and regulatory adherence in pharmaceutical manufacturing.
Ideal Candidate
The ideal candidate is a manufacturing quality assurance specialist with at least 6 years of experience in pharmaceutical or manufacturing environments, skilled in investigations, deviations, and GMP compliance, capable of supporting quality systems and validation processes.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of GMP experience, Less than 6 years of relevant experience, No background in pharmaceutical manufacturing, Unwilling to work in North Chicago, IL, Lack of knowledge of quality regulations
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