Quality Assurance Compliance Specialist

Position: QA Compliance Specialist

Location: Up State or Rensselaer, NY





Key Responsibilities:


- Manage Product Technical Complaints (PTCs) and associated investigations from initiation through closure.
- Coordinate complaint investigations with CMOs, external partners, QC laboratories, and internal Quality teams.
- Manage complaint sample shipment, tracking, retrieval, reconciliation, retention, and destruction activities.
- Ensure sample integrity, chain of custody, documentation, and regulatory compliance.
- Monitor aging/overdue complaints and coordinate with CMOs to ensure timely investigation closure.
- Review investigation reports and supporting Quality documentation.
- Support Post-Marketing Quality Operations, remediation activities, and data integrity assessments.
- Author, review, and revise SOPs, Work Instructions, and Quality procedures.
- Support internal/external audits and inspection-readiness activities.
- Work cross-functionally with QA, QC, Manufacturing, Regulatory, Supply Chain, and external manufacturing partners.
- Ensure compliance with cGMP, FDA regulations, GDP, and applicable Quality Systems.






Preferred Experience:


- Pharmaceutical/Biopharmaceutical Quality Assurance or Quality Compliance experience.
- Product complaints / Product Technical Complaints experience.
- Post-Marketing Quality Operations.
- Experience working with CMOs / external manufacturing partners.
- Complaint and Quality investigations.
- Deviation, CAPA, RCA, Data Integrity, and Audit Support.
- SOP / Work Instruction authoring.
- Experience with systems such as TrackWise, Veeva, Documentum, MasterControl, Salesforce, LIMS, or similar Quality systems.