Quality Operations Specialist

The Quality Operations Specialist plays a critical role on the manufacturing floor, acting as the frontline defense for data integrity and regulatory compliance. Working directly alongside Manufacturing and Operations teams, this role is responsible for reviewing batch records, logbooks, and production documents as they are generated. Rather than just auditing after the fact, the GDP Monitor actively partners with Manufacturing Operators to catch errors early, facilitate immediate and compliant corrections, and mitigate potential deviations before they impact product quality or release timelines.

What You Will Do

Perform real-time reviews of batch records, logbooks, cleaning logs, and production documentation to ensure compliance with GDP, cGMP, and ALCOA+ principles. Identify documentation errors, omissions, and discrepancies as they occur and guide operators through compliant corrections.

Why It Might Be a Fit

The ideal candidate will have a strong working knowledge of FDA 21 CFR Parts 210/211, cGMP, and GDP principles, with the ability to identify documentation errors in fast-paced environments. Strong interpersonal and communication skills are also required to provide constructive feedback effectively.

Requirements

• High School Diploma or GED
• 2–4 years of experience in a regulated manufacturing environment
• Strong working knowledge of FDA 21 CFR Parts 210/211, cGMP, and GDP principles
• Demonstrated attention to detail with the ability to identify documentation errors in fast-paced environments
• Strong interpersonal and communication skills
• Basic math skills and ability to perform calculations related to batch records
• Proficiency with Microsoft Office and standard computer applications

Benefits

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual