Staff Pharmacist | Downingtown, Pennsylvania

A Specialty Compounding Pharmacy seeks a Senior Quality Assurance Specialist for a 13-week contract-to-hire opportunity in Kennett Square, Pennsylvania. This role plays a critical part in maintaining the highest standards of quality across sterile and nonsterile compounding operations, ensuring patient safety and regulatory compliance.

Key Responsibilities:

• Maintain an active quality presence across compounding, cleanroom, dispensing, packaging, and supporting operations.
• Perform routine floor observations to verify alignment with SOPs, training, and controls.
• Detect procedural drifts, documentation gaps, inconsistent practices, and potential compliance or safety risks.
• Provide real-time quality guidance and coaching to pharmacists, technicians, supervisors, and staff.
• Lead and support deviations, investigations, root-cause analyses, CAPAs, risk assessments, and change controls.
• Analyze recurring quality events and suggest sustainable corrective actions.
• Support inspection readiness and continuous improvement efforts.
• Collaborate closely with Operations, Compliance, Training, and Quality leadership.
• Escalate significant quality concerns and pause affected activities when necessary.

Qualifications & Experience:

• Demonstrated expertise in pharmaceutical quality, sterile drug production, or high-volume compounding pharmacy operations.
• Strong hands-on experience with deviations, investigations, CAPA, root-cause analysis, and Quality Management Systems.
• Knowledgeable in sterile compounding regulations and requirements.
• Experience in 503A compounding pharmacies, 503B outsourcing facilities, or sterile pharmaceutical manufacturing is highly desirable.
• Familiarity with USP standards, state Board of Pharmacy requirements, and federal expectations.
• Bachelors degree in pharmacy, pharmaceutical sciences, chemistry, microbiology, biology, engineering, quality, or related field preferred; equivalent experience considered.

Schedule:

• Monday through Friday, day shift (typically 8:00 am4:30 pm)
• Hybrid schedule discussed during interview; consistent weekly hybrid pattern required.

This contract-to-hire position offers the chance to influence quality standards in a specialty pharmacy setting while collaborating with multiple functional teams. Candidates ready to take on a pivotal quality role are encouraged to apply today.