Lead Quality Administrator & Management Representative (39860)

Young Innovations • Houston, TX

7d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Responsibilities

• Act as the Legal Designated/Management Representative (DR) for assigned Board of Pharmacy states as 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.

Benefits

• Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 1-10 employees