Quality Assurance Associate
Henry Schein
Summary
This position is responsible for performing quality control duties such as quality inspections, reviewing batch documentation, sampling finished product, and approving or rejecting batch records in accordance with company procedures, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements.
Job description
Job Overview
This position is responsible for performing quality control duties such as quality inspections, reviewing batch documentation, sampling finished product, and approving or rejecting batch records in accordance with company procedures, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements.
Key Responsibilities
- Perform quality control inspections for relabeling and kitting batches
- Verify accuracy of information listed in batch records
- Sample finished relabeled/repackaged products
- Approve/reject batch records
- Verify package inserts during the receiving process for readability
- Ensure Standard Operating Procedures are adhered to by all TSMs in the relabeling/repackaging operation
- Alert management of any 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 submitted to regulatory bodies
- Assist with regulatory audits and inspections
Specific Knowledge & Skills
- Understand ISO and FDA reporting requirements and follow instruction with some guidance
- Knowledge of Microsoft Word, Excel, and Access required
General Skills & Competencies
- Excellent time management skills and ability to prioritize work
- Attention to detail and accuracy
- Customer service oriented
- Interpersonal communication skills
- Plan and arrange activities
- Good written and verbal communication skills
- Ability to maintain confidential information
- Ability to work in a team environment
- Ability to multi-task
- Capacity to work under pressure
- Proficient in MS Office
Work Experience
Typically 1 or more years of related experience.
Preferred Education
General education, vocational training and/or on-the-job training. Bachelor's degree preferred.
Travel / Physical Demands
- Typically less than 10% travel, restricted to continuing education purposes
- Physical demands: lifting up to 25 lbs
Requirements
- Typically 1 or more years of related experience
- Understand ISO and FDA reporting requirements
- Knowledge of Microsoft Word, Excel, and Access required
- Excellent time management skills and ability to prioritize work
- Attention to detail and accuracy
- Customer service oriented
- Interpersonal communication skills
- Good written and verbal communication skills
- Ability to maintain confidential information
- Ability to work in a team environment
- Ability to multi-task
- Capacity to work under pressure
- Proficient in MS Office
- Bachelor's degree preferred
Company overview
Henry Schein, Inc. is a leading global healthcare solutions company that serves as the world's largest provider of healthcare products and services to office-based dental and medical practitioners. Founded in 1932 and headquartered in Melville, New York, the company operates as a Fortune 500 corporation and S&P 500 component with extensive operations across 33 countries and territories. Henry Schein specializes in distributing dental and medical supplies, equipment, pharmaceuticals, and technology solutions to more than 1 million customers worldwide. The company offers comprehensive business, clinical, technology, and supply chain solutions designed to help healthcare professionals improve operational efficiency and clinical outcomes. With a centralized and automated distribution network featuring over 300,000 branded products, Henry Schein has established itself as a trusted advisor in the healthcare industry, consistently recognized as one of the World's Most Ethical Companies for 14 consecutive years. The company's revenue reached $12.7 billion in 2024, demonstrating sustained growth since its public listing in 1995.