The Quality Specialist plays a key role in upholding product integrity by monitoring quality systems and supporting adherence to industry regulations. This position involves conducting audits, reviewing documentation, and identifying opportunities for process improvement.
Responsibilities
- Evaluate quality control procedures to ensure alignment with regulatory requirements
- Support investigations into deviations and assist in corrective action planning
- Review batch records and related documentation for accuracy and completeness
- Collaborate with cross-functional teams to resolve quality-related issues
- Contribute to continuous improvement initiatives across manufacturing and testing processes
Qualifications
Applicants should hold a degree in a scientific or engineering discipline and have prior experience in a regulated environment. Familiarity with FDA, ISO, or other quality standards is essential. Strong attention to detail, organizational abilities, and clear communication skills are required to succeed in this role.