Senior Quality Assurance Associate

As a Senior Quality Assurance Associate, you will provide strategic quality support to warehouse and distribution operations. This role ensures compliant receipt, inspection, and release of pharmaceuticals through adherence to GDP, DSCSA serialization requirements, and FDA import regulations. You will independently manage deviations and nonconformances, lead supplier quality assessments, drive CAPA closure and verification, maintain regulatory compliance documentation, and support Quality leadership on cross-functional initiatives and regulatory interactions.

Responsibilities

Lead receipt and inspection of pharmaceutical products for compliance with GDP, DSCSA, and regulatory requirements.
Verify DSCSA serialization, lot traceability, and chain of custody documentation.
Identify and manage suspect or illegitimate product reports.
Monitor warehouse environmental conditions and storage compliance.
Inspect returned goods for disposition and regulatory compliance.
Write, revise, and approve QA documentation (SOPs, procedures, work instructions).
Investigate and resolve deviations and nonconformances.
Execute QA review and approval of product release documentation.
Support continuous improvement activities to enhance Quality operations and regulatory compliance.

Qualifications - Skills & Requirements

Good knowledge of Microsoft Office applications.
Organizational and leadership skills.
Excellent data collection and analysis skills.
Keen attention to detail, and Critical/logical thinking
Strong knowledge of GMP regulations and their application.
Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.
Excellent verbal, written, and teamwork communication skills.

Education & Experience

Minimum B.S. degree; preferably in a scientific field.
2-3 years of experience in Quality Assurance or a similar field within the pharmaceutical industry.
Oracle experience (preferred).
Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
Dental Benefits with three dental plan options through CIGNA
Vision Plan with two plan options through VSP
Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
Disability Insurance, Voluntary Short-Term Disability and State Disability
Long-Term Disability (LTD), State (short term) disability – where applicable
FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
HSA (Health Savings Account)
401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
Critical Illness and Accidental Insurance
Legal and Identity Theft Insurance
Paid Time Off - Paid vacation, PTO, Holiday