Quality Assurance Associate (Pharmaceutical Distribution) - Designated Rep

Job Description

Job Description

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. The incumbent will play a vital role in ensuring the accuracy and consistency of our Certificate of Analysis (COA) post analytical testing. They will be an integral part of our efforts to maintain the highest standards of quality for our peptide products. This role is accountable for ensuring full compliance with state and federal regulations governing pharmaceutical distribution, including oversight of quality systems, licensure, and daily operations. The ideal candidate will bring strong experience in pharmaceutical wholesale distribution, regulatory compliance, and operational oversight, and will play a critical role in maintaining an inspection-ready, compliant, and efficient facility.

Designated Representative:

• 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
• Coordinate 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 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).

Benefits

For employees:

-100% employer-paid MEDICAL HMO

-MEDICAL PPO

-DENTAL PPO

-VISION

-100% employer-paid Basic Life/AD&D + ST Disability

-4% 401K Match (Immediately vested Safe Harbor)

-FSA

PTO: 15 days total (vacation/personal days) + 5 sick days + holidays

(the 13 vacation days accrue + earn more days when you hit milestone years)