Senior Quality Assurance Specialist
Senior Quality Assurance Specialist
Location: Kennett Square, PA
Pay: $45.00–$52.00/hour
Employment Type: 13-Week Contract-to-Hire
Schedule
Monday–Friday, approximately 8:00 AM–4:30 PM.
Potential hybrid schedule to be discussed during the interview.
Any agreed-upon hybrid schedule must remain consistent each week.
Position Overview
Seeking a Senior Quality Assurance Specialist to provide hands-on Quality oversight within a specialty compounding pharmacy. This floor-based role focuses on monitoring daily operations, identifying compliance and patient safety risks, coaching staff, and driving continuous improvement.
Key Responsibilities
Oversee Quality practices across sterile and nonsterile compounding, cleanroom operations, dispensing, fulfillment, and packaging.
Conduct floor observations to ensure compliance with SOPs, training, and established quality standards.
Identify procedural inconsistencies, documentation gaps, and potential compliance or patient safety risks.
Provide real-time Quality guidance and coaching to pharmacists, technicians, and operational staff.
Lead and support deviations, investigations, root-cause analyses, CAPAs, risk assessments, and change controls.
Identify recurring quality trends and recommend corrective actions.
Support inspection readiness and continuous improvement initiatives.
Collaborate with Operations, Compliance, Training, and Quality leadership.
Escalate significant quality concerns and pause affected activities when necessary.
Qualifications
Experience in pharmaceutical Quality Assurance, sterile drug production, pharmaceutical operations, or high-volume compounding.
Hands-on experience with deviations, investigations, CAPA, root-cause analysis, and Quality Management Systems (QMS).
Working knowledge of sterile compounding and applicable regulatory requirements, including USP standards and state and federal regulations.
Experience in a 503A pharmacy, 503B outsourcing facility, or sterile pharmaceutical manufacturing environment preferred.
Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biology, Engineering, Quality, or a related field preferred. Equivalent relevant experience may be considered
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