QA Operations Specialist II/III

Work Location: Harris County, Texas

Summary:

Seeking a detail-oriented QA Operations Specialist II/III to support quality operations in a regulated pharmaceutical or biotechnology environment. This role involves day-to-day quality activities, manufacturing support, documentation, and deviation management in compliance with GMP standards and regulatory requirements. Ideal for professionals aiming to expand their expertise in a collaborative, science-driven setting.

Responsibilities:

• Oversee and execute line-clearance and change-over tasks to facilitate manufacturing processes.
• Administer the disposition, hold, and rejection of various materials in compliance with GMP guidelines.
• Ensure accurate generation and reconciliation of in-process and finished product labels.
• Review and approve executed documentation from manufacturing, quality control, and related functions.
• Initiate, draft, and manage deviations, CAPAs, and Change Controls for quality operations.
• Develop, review, and authorize procedures to uphold and enhance quality standards.
• Collaborate with cross-functional teams to optimize batch records and operational procedures.
• Perform additional tasks as needed to support the overall quality operations function.

Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field.
• Minimum 2 years of experience in Quality Assurance or a GMP-regulated role (Level II); 4+ years preferred for Level III.
• Direct experience with deviation management, CAPA creation, and Change Control processes.
• Knowledge of batch record review, label reconciliation, and document control.
• Understanding of GMP principles and familiarity with regulations such as US FDA, ISO 9001, and ISO 13485.
• Experience with line-clearance, material disposition, and in-process quality oversight in manufacturing.
• Strong communication skills for documenting quality events and collaborating across teams.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
• Analytical and problem-solving skills with a focus on root cause analysis.
• Proficiency in Microsoft Office Suite or similar software.

Published Category: Quality & Validation