Quality Manager

Quality Manager at ClinLab Solutions Group Quality Manager at ClinLab Solutions Group in Boerne, Texas Posted in 1 day ago.

Type:

full-time

Job Description:

Job Title:

Quality Manager Work Location:

Kendall County, Texas Summary:

This position is responsible for overseeing internal quality assurance functions, including batch release and the execution of various quality systems such as complaints, events, CAPAs, effectiveness checks, annual product reviews, and other quality-related tasks.

Responsibilities:

Act as the subject matter expert for quality matters related to manufacturing, packaging, warehousing, and supporting operations. Review and approve GMP master documents and supervise the release of manufactured batches. Manage internal and supplier audit programs to ensure compliance with quality standards. Oversee and approve change controls, deviations, CAPAs, non-conformances, and customer complaint investigations. Communicate quality matters with customers as outlined in quality agreements. Facilitate and host customer audits to support the review of manufacturing and quality systems. Participate in and support regulatory audits conducted by health authorities. Coordinate and approve annual product reviews and share approved reports with business customers as required.

Qualifications:

Bachelor's degree required. At least 5 years of related experience and/or training, or an equivalent combination of education and experience.

Published Category:

Quality & Validation