The Pharmacist provides professional oversight and technical leadership in the CGMP manufacturing and aseptic processing of sterile pharmaceutical products within STAQ Pharma’s 503B Outsourcing Facility. This role ensures that all manufacturing, testing, and documentation activities comply with applicable federal and state regulations, industry standards, and internal quality systems to maintain the highest levels of product quality, safety, and efficiency.

The Pharmacist plays a key role in coordinating with Quality Control (QC) and Quality Assurance (QA) to ensure that raw materials, in-process components, and finished products meet established specifications. The position supports investigation and resolution of quality events, reviews and approves batch records, and contributes to continuous improvement initiatives designed to enhance manufacturing consistency and regulatory compliance.

Collaboration with cross-functional teams—including Quality, Manufacturing Sciences & Technology, Sales and Marketing, and external laboratories—is essential to support product development, technology transfer, and ongoing production across multiple sites.

This position requires an active pharmacist license in good standing, preferably in multiple states. The ideal candidate demonstrates a thorough understanding of pharmacy regulations, CGMP requirements, Quality Control and Quality Assurance principles, aseptic technique, and sterile compounding best practices to ensure the compliant production and distribution of high-quality compounded sterile preparations.

The Pharmacist’s responsibilities include:

• Review and approve compounding formulation records for completeness, accuracy, and regulatory compliance.
• Maintain a comprehensive understanding of applicable Standard Operating Procedures (SOPs) and training documents.
• Assist in the formulation and aseptic filling of sterile and non-sterile drug products in accordance with CGMP and FDA guidelines.
• Create, revise, and maintain SOPs, batch records, and item specifications to ensure compliance with CGMP requirements and internal quality standards.
• Develop stability protocols and final reports for new and prospective drug products.
• Stay current on FDA, USP, and industry guidance to ensure continued regulatory compliance.
• Conduct internal self-audits and implement corrective and preventive actions to support audit readiness for inspections by the FDA, suppliers, and other regulatory entities.
• Ensure compliance with all labeling requirements for STAQ Pharma’s product catalog.
• Assist in the procurement, qualification, and validation of new instruments and production equipment.
• Maintain an active pharmacist license in good standing.
• Prepare and revise technical and quality documentation in accordance with CGMP standards.
• Manage laboratory portal submissions, review lab paperwork, and track product and stability testing data.
• Identify, document, and support resolution of irregularities, deviations, and non-conformances.
• Author and review technical protocols and final reports.
• Provide pharmacist oversight and supervision during production operations.
• Assist in investigation, documentation, and resolution of customer complaints in collaboration with Quality to ensure compliance with CGMP and internal procedures.
• Perform other duties as reasonably assigned by management or supervision.