Quality Assurance Associate (Pharmaceutical Distribution) - Designated Rep

About the role

We are seeking a Quality Associate to join our team. This person needs to be a qualified Designated Representative (DR/CDR) to serve as the responsible person for our licensed wholesale drug distribution facility.

Responsibilities

• Serve as the Designated Representative (California) and/or Certified Designated Representative (Florida) for the facility, meeting all statutory requirements for licensure and operational oversight
• Maintain full compliance with applicable regulations, including DSCSA, state Board of Pharmacy requirements, and industry standards for drug storage, handling, and distribution
• Lead and manage all compliance-related activities, including audits, inspections, and ongoing regulatory readiness
• Develop, implement, and maintain SOPs covering distribution, storage, recordkeeping, returns, recalls, and diversion/suspicious order monitoring
• Act as the primary point of contact for regulatory agencies and support state licensing and NABP accreditation activities
• Oversee repackaging operations to ensure compliance with all applicable regulatory and quality standards
• Ensure proper documentation, record retention, and inventory controls are maintained in accordance with regulatory requirements
• Provide leadership and oversight of day-to-day distribution operations to ensure compliance and operational efficiency
• Supervise shipping and receiving activities, ensuring accurate documentation, timely processing, and adherence to compliance standards
• Cook with carriers and internal teams to support efficient and compliant distribution operation
• Quality Work directly with our manufacturing vendors and clients for document-creation and relationship management
• Review and verify the COAs for accuracy and completeness after analytical testing
• Cross-check the analytical data and results against predefined quality standards and acceptance criteria
• Support internal teams in the interpretation and understanding of COA results
• Initiate non-conformance reports and corrective actions when deviations are identified
• Document and report any deviations or anomalies in the COA to the Quality Control Supervisor
• Participate in internal audits to ensure adherence to quality control procedures and protocols
• Contribute to continuous improvement initiatives aimed at enhancing quality control processes
• Comply with all regulatory guidelines and procedures relevant to pharmaceutical peptide production

Requirements

• Current Florida CDR and/or California Designated Representative licensure, or eligibility and willingness to obtain required licensure promptly upon hire
• Bachelor's degree in Chemistry, Biology, or a related scientific discipline preferred
• Minimum 1-2 years of experience in quality control or assurance in a pharmaceutical or biotech industry, preferably in a CDMO environment preferred
• Strong working knowledge of Board of Pharmacy regulations, GDP practices, and pharmaceutical supply chain compliance (and potentially DSCSA down the line)
• Demonstrated experience supporting regulatory inspections, audits, and licensing processes
• Prior experience in a supervisory or managerial role within a regulated pharmaceutical environment
• Ability to serve as the designated responsible person for the facility and be physically present full-time as required by law

Preferred Experience

• Familiarity with NABP accreditation processes
• Familiarity with warehouse and distribution systems, including shipping platforms
• Proficiency in Microsoft Excel (e.g., pivot tables, data tracking)
• Knowledge and understanding of analytical testing methods and processes
• Familiarity with industry standards and regulations such as GMP, FDA, EMA, etc.
• Strong attention to detail with the ability to identify errors and inconsistencies
• Excellent written and verbal communication skills
• Ability to work in a fast-paced, team-oriented environment
• Proficient in using Microsoft Office suite (Word, Excel, PowerPoint)