QA Specialist

Location: Chester County, PA | Hybrid

Requirements: Approximately 10+ years of progressive experience in pharmaceutical Quality Assurance, sterile drug production, pharmaceutical operations, or a high-volume compounding pharmacy environment strongly preferred. Strong hands-on experience with deviations, investigations, CAPAs, root-cause analysis, Quality Management Systems (QMS), and compliance processes. Working knowledge of sterile compounding and applicable regulatory requirements, including USP standards, FDA regulations, GMP principles, and state Board of Pharmacy requirements. Experience working within a regulated 503A compounding pharmacy, 503B outsourcing facility, sterile pharmaceutical manufacturing, or similar production environment highly desirable.

Job Duties: Maintain an active Quality presence across sterile and nonsterile compounding, cleanroom, dispensing, fulfillment, packaging, and supporting pharmacy operations. Conduct routine floor observations to ensure day-to-day practices align with established SOPs, training, documentation standards, and quality controls. Identify procedural deviations, documentation deficiencies, inconsistent practices, and potential compliance or patient-safety risks in real time. Provide hands-on Quality guidance and coaching to pharmacists, pharmacy technicians, supervisors, and operational staff. Initiate and support deviations, investigations, root-cause analyses, CAPAs, risk assessments, and change controls through resolution. Monitor recurring quality events and trends, recommending sustainable corrective and preventive actions to strengthen operations. Support inspection readiness and continuous improvement efforts while partnering closely with Operations, Compliance, Training, and Quality leadership.

Schedule: Monday-Friday, 8:00 AM-4:30 PM

Work Arrangement: Hybrid, with 2-3 days onsite per week in Chester County, PA

Pay Range: Up to $110,000/annuallyNHC-1479159_1793033887