QA Operations Specialist II/IIIClinLab Solutions Group • Houston, Texas, United States

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QA Operations Specialist II/III

ClinLab Solutions Group

Houston, Texas, United States

Houston, Texas, United States

À propos

We are seeking a detail-oriented and experienced QA Operations Specialist at the II or III level to join a dynamic Quality team within a regulated pharmaceutical or biotechnology environment. In this role, you will be an integral part of day-to-day quality operations, supporting manufacturing, documentation, and deviation management activities in alignment with GMP standards and regulatory requirements. This is an excellent opportunity for a quality professional looking to deepen their expertise and grow within a collaborative, science-driven organization. KEY RESPONSIBILITIES Perform line-clearance and change-over activities to support manufacturing operations. Manage disposition, hold, and rejection of raw materials, starting materials, and in-house prepared materials in accordance with GMP requirements. Generate and reconcile in-process and Drug Product labels with accuracy and compliance. Review and approve executed documents related to manufacturing operations, QC, and other departments. Initiate and author deviations, CAPAs, and Change Controls associated with Quality Operations practices. Create, review, and approve procedures and practices within Quality Operations to implement and maintain quality standards. Partner cross-functionally with other departments to implement and optimize batch records, practices, and procedures. Perform other duties as assigned in support of the Quality Operations function. QUALIFICATIONS Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related discipline required. 2 or more years of experience in Quality Assurance or a GMP-regulated role within the pharmaceutical, biotechnology, or related industry (Level II); 4 or more years of progressive QA experience preferred for Level III consideration. Hands-on experience with deviation management, CAPA authoring, and Change Control processes. Working knowledge of batch record review, label reconciliation, and document control practices. Solid understanding of GMP principles and familiarity with Health Authority regulations such as US FDA, ISO 9001, and ISO 13485. Familiarity with line-clearance, material disposition, and in-process quality oversight in a manufacturing environment. Strong verbal and written communication skills, with the ability to clearly document quality events and collaborate across departments. Excellent attention to detail, organizational skills, and the ability to manage multiple priorities and meet deadlines in a fast-paced environment. Strong analytical and problem-solving capabilities with a root cause-oriented mindset. Proficiency with Microsoft Office Suite or related software.

Houston, Texas, United States

Compétences linguistiques

English

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