Quality Assurance Associate

Henry Schein; Virginia; On-site; USD 65,000 - 75,000; Full time

Job summary

Henry Schein is seeking a Quality Control professional to perform inspections, review batch documentation, and sample finished Relabeled/Repackaged products. You will approve or reject batch records and ensure package inserts are readable during receiving processes.

Ideal candidates will understand ISO and FDA reporting requirements, with strong MS Word/Excel/Access skills and a focus on detail, accuracy, and teamwork in a fast-paced environment.

Qualifications

• Typically 1+ years of related experience.
• Bachelor’s degree preferred.

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; recommend to management enhancements to the process.
• Work closely with the Operations to ensure compliance with cGMPs.
• Issue inspection activity reports to management and others as required.
• Assist in obtaining documentation that will be submitted to regulatory bodies.
• Assist with regulatory audits and inspections.

Skills

Time management

Attention to detail

Communication

Teamwork

Multi-tasking

Education

Bachelor’s degree preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Job description

Job Overview

This position is responsible for performing quality control duties such as quality inspections, reviewing batch documentation, samples finished product and approving or rejecting batch records in accordance with company procedures, current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.

Key Responsibilities

Quality Control responsibilities include:

• 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; recommend to management enhancements to the process.
• Work closely with the Operations to ensure compliance with cGMPs.
• Issue inspection activity reports to management and others as required.
• Assist in obtaining documentation that will be 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 the ability to prioritize work.
• Attention to detail and accuracy.
• Customer service oriented.
• Interpersonal communication skills.
• Plan and arranges 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% of travel and travel is restricted only for the purpose of continuing education. Physical demands required: lifting up to 25lbs.

Equal Employment Opportunity

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Accommodation Request

If you are unable or limited in your ability to complete the application process, including the use or access of www.henryschein.com/careers, as a result of a physical or mental impairment, you can request reasonable accommodations. Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.

US Candidates: [e-mail]
UK and Ireland Candidates: [e-mail]
Australia and New Zealand Candidates: [e-mail]
Malaysia Candidates: [e-mail]
Italy Candidates: [e-mail]

Work Arrangements

It is important to us to offer different types of work arrangements. Please see the types we offer below:

• Work From Home: Work is performed directly from the TSM's home office.
• Hybrid: Time is scheduled between working from a TSM home office and at a company facility, as required.
• Onsite: Work is performed exclusively at a company facility.
• Field: Position requires traveling to different locations within a specific geographic territory, as assigned.

Company Overview

Over 90 years ago Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners. Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our Team Schein Values as our founders would have wanted. We live those values by ensuring that our culture focuses on the wellness of our team, which we accomplish by providing a safe space for individuals to develop and contribute authentically, with opportunities to give back to society and the communities where we live and work. No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place. Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants.