Quality Assurance Associate (Pharmaceutical Distribution) - Designated Rep

Valley Forge Pharma•Malvern, PA

9d•Onsite

About The Position

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.

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

Nice To Haves

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).

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
Coordinate with carriers and internal teams to support efficient and compliant distribution operation
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.