Staff Pharmacist - West Chester, Pennsylvania
A Specialty Compounding Pharmacy is seeking an experienced Senior Quality Assurance Specialist for a 13-week contract-to-hire assignment in Kennett Square, Pennsylvania. This role plays a critical part in maintaining quality standards across sterile and nonsterile compounding, cleanroom operations, dispensing, fulfillment, and packaging.
Responsibilities:
- Maintain an active Quality presence on the floor, ensuring alignment of actual practices with SOPs, training, and established controls
- Conduct routine observations to identify procedural drift, documentation issues, inconsistent practices, and potential compliance or patient-safety risks
- Provide real-time Quality guidance and coaching to pharmacists, technicians, supervisors, and operational staff
- Lead and support deviations, investigations, root-cause analysis, CAPAs, risk assessments, and change controls
- Detect recurring quality trends and recommend sustainable corrective actions
- Support inspection readiness and continuous improvement initiatives
- Partner closely with Operations, Compliance, Training, and Quality leadership teams
- Escalate significant quality concerns and pause activities if necessary for evaluation
Schedule:
- Monday to Friday, Day Shift (typically 8:00 AM to 4:30 PM or similar)
- Hybrid schedule discussion during interview; consistent weekly schedule required
Qualifications and Desired Experience:
- Strong background in pharmaceutical Quality, sterile drug production, or high-volume compounding pharmacy environments preferred
- Hands-on experience with deviations, investigations, CAPA, root-cause analysis, and Quality Management Systems (QMS)
- Knowledge of sterile compounding and regulatory/quality requirements
- Experience in 503A compounding pharmacies, 503B outsourcing facilities, or sterile pharmaceutical manufacturing is highly desirable
- Familiarity with USP standards, state Board of Pharmacy regulations, and federal expectations
- Bachelors degree in pharmacy, pharmaceutical sciences, chemistry, microbiology, biology, engineering, quality, or related field preferred; equivalent relevant experience may be considered
This position offers a valuable opportunity to contribute to quality assurance in a specialized pharmacy setting with potential for permanent employment. Candidates with strong quality assurance expertise in pharmaceutical environments are encouraged to apply and discuss fit for this contract-to-hire role.
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