Job Description
Experience Required: Minimum 3 Years
Education: Bachelor’s Degree Preferred
We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement. The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes. This position is an on-site office position. Must live in the local area.
Key Responsibilities:- Implement and maintain quality standards across all stages of the process
- Ensure compliance with internal procedures, regulatory requirements, and quality systems
- Assess potential quality and compliance risks and provide recommendations for mitigation
- Take ownership of quality control activities related to:
- Service Processes
- Testing and operations
- Production processes
- Finished products and services
- Facilitate internal audits and regulatory inspections
- Coordinate and support quality training initiatives
- Apply professional expertise and independent judgment to resolve quality-related issues
- Collaborate cross-functionally to drive continuous improvement and compliance excellence
Qualifications:- Bachelor’s degree preferred or equivalent in experience
- Minimum of 3 years of relevant quality assurance or quality control experience
- Strong understanding of quality systems, compliance standards, and regulated environments
- Experience supporting audits and regulatory inspections
- Ability to work independently with minimal supervision
- Strong analytical, organizational, and communication skills
- Practical knowledge gained through hands-on industry experience preferred
Preferred Skills:- Experience in medical device, pharmaceutical, biotech, or healthcare environments
- Familiarity with GMP, GLP, GCP, FDA, or ISO standards
- Strong problem-solving and risk assessment capabilities
