Quality Assurance Associate

Henry Schein•Bastian, VA

About The Position

This position performs quality control duties, including inspections, batch-documentation review, finished-product sampling, and approval or rejection of 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 with Operations to ensure cGMP compliance, and assists with regulatory documentation, audits, and inspections. Travel is typically less than 10% and is limited to continuing education. The position requires 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 and work under pressure.
Proficiency in Microsoft Office.
Ability to lift up to 25 pounds.

Nice To Haves

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

Responsibilities

Perform quality control inspections for relabeling and kitting batches.
Verify the accuracy of information in batch records.
Sample finished relabeled or repackaged products.
Approve or reject batch records.
Verify package inserts for readability during receiving.
Ensure Standard Operating Procedures are followed by 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.