Staff Pharmacist | Coatesville, Pennsylvania

Join a specialty compounding pharmacy as a Senior Quality Assurance Specialist in Kennett Square, Pennsylvania. This 13-week contract-to-hire position offers a vital role in maintaining and enhancing quality standards throughout sterile and nonsterile compounding operations in a high-volume, regulated environment.

Key Responsibilities:

• Maintain a consistent Quality presence across sterile and nonsterile compounding, cleanroom, dispensing, fulfillment, packaging, and supporting operations.
• Conduct routine floor observations to ensure compliance with SOPs, training, and established controls.
• Identify procedural deviations, documentation gaps, workarounds, and potential patient-safety risks.
• Provide real-time Quality guidance and coaching to pharmacists, technicians, supervisors, and operational staff.
• Lead and support investigations, deviations, root-cause analysis, CAPAs, risk assessments, and change controls.
• Analyze recurring quality events and trends, recommending effective corrective actions.
• Support inspection readiness and continuous improvement initiatives.
• Collaborate closely with Operations, Compliance, Training, and Quality leadership.
• Elevate significant Quality concerns and pause activities when necessary for evaluation.

Qualifications and Desired Experience:

• Strong background in pharmaceutical Quality, sterile drug production, pharmaceutical operations, or a sophisticated high-volume compounding pharmacy environment.
• Proficient in deviation management, investigations, CAPA, root-cause analysis, and Quality Management Systems (QMS).
• Working knowledge of sterile compounding processes and applicable regulatory and quality requirements.
• Experience in a 503A compounding pharmacy, 503B outsourcing facility, or sterile pharmaceutical manufacturing preferred.
• Familiarity with USP standards, state Board of Pharmacy requirements, and federal regulations.
• Bachelors degree in pharmacy, pharmaceutical sciences, chemistry, microbiology, biology, engineering, quality, or related field is preferred; equivalent experience considered.

Schedule:

• Monday through Friday, Day Shift (typically 8:00 AM 4:30 PM)
• Hybrid work schedule to be discussed during interview; consistent weekly schedule required.

This opportunity offers a chance to advance your career in quality assurance within a specialized pharmaceutical setting while impacting patient safety and operational excellence. Take the next step in your professional journey by applying today.