Lead Quality Administrator On-Site

Company Summary:

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Position Overview:

The Lead Quality Administrator & Management Representative supports the Quality Assurance Manager in maintaining regulatory compliance and execution of Quality and Regulatory Affairs (QRA) activities for the facility. This role performs advanced quality administration tasks, serves as a subject matter expert for controlled substance distribution processes, and provides functional leadership and training to the Quality team. The position may act as the site’s Designated Representative (DR) for certain Board of Pharmacy jurisdictions and serves as a back-up to the Quality Assurance Manager during inspections and regulatory activities.

You’ll like this role if:

• Enjoy helping people and solving problems in a collaborative environment.

Why You’ll Love Working Here:

• Medium sized company – not too big, not too small – just enough to get things done and see your impact.
• Did we say benefits? Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!

Who you’ll work with:

• Quality Assurance Manager, Quality Administrators, Sales and Customer Service, Distribution and Operations

What You’ll Do:

• Lead & Regulatory Support Responsibilities:
  • Act as the Legal Designated/Management Representative (DR) for assigned Board of Pharmacy states as required. The DR must meet applicable BOP legal requirements and may be required to complete state-required training and examinations (e.g., Florida, California). The DR supports regulatory compliance and must be physically located at the licensed facility when required.
  • Serve as a subject matter expert for controlled substance distribution processes, including DEA Form 222, CSOS transactions, suspicious order monitoring, and controlled substance recordkeeping.
  • Provide functional leadership and training to Quality Administrators and serve as a departmental resource for quality procedures and regulatory requirements.
  • Support the Quality Assurance Manager with daily quality operations and assist with regulatory inspections, audits, and related documentation.
  • Serve as an escalation point for complex quality administration issues.

• Enter or verify DEA Form 222 and electronic CSOS orders via ERP system or order evaluation checklist as required.
• Conduct DEA License validation and Purcos analysis for DEA Form 222 transactions.
• Identify & report potential suspicious orders (SORS) and DEA Form 106 incidents to the Quality Assurance Manager.
• Pick, pack and ship controlled substances in accordance with regulatory and company requirements.
• Process RMAs and credits, ensuring proper documentation and system entry.
• Communicate with Sales and Customer Service teams via Hubspot, email and Microsoft Teams regarding order and shipment matters.
• Assist with cold shipment calculations and related documentation.
• Provide administrative support for internal and external audits and other departmental administrative tasks as needed.
• Conduct or verify controlled substance inventories in accordance with regulatory requirements.
• Assist with Know Your Customer (KYC) processes as a backup when needed.
• Perform other duties as assigned.

What You’ll Bring:

• High School Diploma or GED required; Associate’s degree preferred
• 3+ years previous experience in pharmaceutical distribution, drug wholesaling, medical device distribution, or related regulated industry preferred.
• Experience serving as a trainer, subject matter expert, or lead within a team environment preferred.
• Demonstrated ability to interpret and follow regulatory and quality procedures.
• Strong understanding of DEA, FDA, and Board of Pharmacy regulatory environments related to pharmaceutical distribution.
• Ability to train and mentor team members on quality and regulatory processes
• Strong Attention to detail and documentation accuracy.
• Ability to prioritize work and support department operations in a fast-paced regulatory environment.

Technical Skills

• Strong proficiency in verbal and written communication in communications, with the ability to convey information clearly, accurately, and professionally across all levels of the organization.

Physical Requirements/Working Locations –

Office/Remote Environment

This position is based in an office environment and is primarily sedentary in nature. It requires regular use of standard office equipment, including computers, phones, photocopiers, scanners, filing cabinets, and fax machines. Some roles may involve wearing a headset and sustained computer use for 8 or more hours per day. Employees may be required to sit, stand, or walk for extended periods, and occasional bending, lifting, or carrying items up to 50 pounds may be necessary.

Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.