Quality Assurance Associate

Henry Schein • Bastian, VA

1d

About The Position

The Quality Assurance Associate performs quality control duties, including quality inspections, review of batch documentation, sampling finished products, and approving or rejecting batch records in accordance with company procedures, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements. The role supports quality and compliance in relabeling and repackaging operations, works closely with Operations, and assists with regulatory documentation, audits, and inspections.

The position typically requires one or more years of related experience. General education, vocational training, and/or on-the-job training is preferred; a bachelor’s degree is also preferred. Travel is typically less than 10% and is restricted to continuing education. Physical demands include lifting up to 25 pounds.

Requirements

• Typically one or more years of related experience.
• Understand ISO and FDA reporting requirements and follow instructions with some guidance.
• Knowledge of Microsoft Word, Excel, and Access.
• Excellent time-management skills and ability to prioritize work.
• Attention to detail and accuracy.
• Customer-service orientation.
• Interpersonal communication skills.
• Ability to plan and arrange activities.
• Good written and verbal communication skills.
• Ability to maintain confidential information.
• Ability to work in a team environment.
• Ability to multitask.
• Capacity to work under pressure.
• Proficiency in MS Office.

Nice To Haves

• General education, vocational training, and/or on-the-job training.
• Bachelor’s degree preferred.

Responsibilities

• Perform quality control inspections for relabeling and kitting batches.
• Verify the accuracy of information listed in batch records.
• Sample finished relabeled and repackaged products.
• Approve or reject batch records.
• Verify package inserts for readability during the receiving process.
• Ensure Standard Operating Procedures are followed by all TSMs in the Relabeling/Repackaging operation.
• Alert management to potential quality issues and recommend process enhancements.
• Work closely with Operations to ensure compliance with cGMPs.
• Issue inspection activity reports to management and others as required.
• Assist in obtaining documentation for submission to regulatory bodies.
• Assist with regulatory audits and inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed