Pharmacy | West Chester, Pennsylvania

This leadership role is focused on maintaining and enhancing quality assurance within a specialized 503A compounding pharmacy. The Quality Assurance Supervisor will oversee the quality assurance team and processes, ensuring all compounded products comply with company standards and stringent regulatory requirements. This position demands a commitment to established protocols, with little room for deviation from current practices.

Key Responsibilities:

• Develop, implement, and manage quality assurance processes and metrics for product compliance.
• Interpret and uphold quality assurance standards specific to pharmaceutical compounding.
• Conduct routine audits and inspections to verify adherence to procedures and regulatory mandates.
• Collaborate cross-functionally to ensure quality integration across all operations.
• Train and guide the QA team on effective quality assurance methodologies.
• Investigate and resolve customer complaints and non-conformance issues.
• Analyze quality trends and data, driving continuous improvement and corrective actions.
• Maintain compliance with federal, state, and local regulations, including USP <795>, <797>, and <800> standards pertinent to 503A pharmacy operations.

Qualifications and Desired Experience:

• Proven experience in pharmaceutical quality assurance within a compounding pharmacy setting.
• Solid understanding of USP <795>, <797>, and <800> guidelines and applicable regulatory framework.
• Experience leading audits and managing regulatory inspections.
• Proficiency with Quality Management Systems (QMS), document control software, and knowledge of data integrity principles (21 CFR Part 11 preferred).
• Strong leadership and communication skills.

Schedule:

• Monday through Friday, 8:30 AM – 5:30 PM
• Saturday availability as needed (flexible)

Location: Kennett Square, Pennsylvania

This position is a 13-week contract with potential for hire, ideal for candidates who respect established processes and seek to contribute within an established quality framework in compounding pharmacy operations.

Qualified candidates are encouraged to submit an updated resume and relevant credentials for consideration. Apply now to advance your career in pharmaceutical quality assurance.