Job Description
Job Description
Doctor of Pharmacy (PharmD) degree, active Pharmacist license, and minimum 1+ years Pharmacist experience required. Applicants who do not meet these qualifications will not be considered.
A specialty compounding pharmacy is seeking a Senior Quality Assurance Specialist for a 13-week contract to hire assignment in Kennett Square, PA. This role plays a critical part in maintaining the integrity and compliance of sterile and nonsterile compounding processes, ensuring patient safety and regulatory adherence.
Key Responsibilities:
- Maintain active quality oversight across compounding, cleanroom operations, dispensing, fulfillment, packaging, and related activities.
- Conduct routine floor observations to verify adherence to SOPs, training, and quality controls.
- Detect procedural deviations, documentation gaps, inconsistent practices, and potential safety or compliance risks.
- Provide real-time quality coaching and guidance to pharmacists, technicians, supervisors, and operational staff.
- Initiate and support quality event investigations, deviations, root-cause analyses, CAPAs, risk assessments, and change controls.
- Identify quality trends and recommend sustainable corrective actions.
- Support inspection readiness and continuous quality improvements.
- Collaborate closely with Operations, Compliance, Training, and Quality leadership teams.
- Escalate significant quality concerns and pause activities when necessary for appropriate evaluation.
Desired Experience:
- Hands-on experience with pharmaceutical quality assurance, preferably in sterile drug production or high-volume compounding pharmacy settings.
- Proven skills in managing deviations, investigations, CAPA, root-cause analysis, and Quality Management Systems (QMS).
- Thorough understanding of sterile compounding, USP standards, regulatory requirements, and federal/state Board of Pharmacy expectations.
- Experience in 503A compounding pharmacies, 503B outsourcing facilities, or sterile pharmaceutical manufacturing is highly desirable.
- Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, microbiology, biology, engineering, quality, or related fields preferred. Equivalent relevant experience will be considered.
Schedule:
- Monday through Friday, Day Shift (typically 8:00 AM – 4:30 PM or similar)
- Hybrid work schedule with consistent weekly arrangement to be discussed during the interview.
This position offers a dynamic environment to apply your quality assurance expertise in a specialized pharmacy setting. Qualified professionals ready to support and enhance quality operations are encouraged to apply now for this contract to hire opportunity.
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