Staff Pharmacist

503A Compounding Pharmacist

• Department: Pharmacy Operations
• Reports To: Pharmacist-in-Charge / Director of Pharmacy
• Classification: Non-Exempt, based on company classification
• Location: Optimal Balance Pharmacy

Position Summary

The 503A Compounding Pharmacist is responsible for providing pharmacist oversight of the compounding department and ensuring compounded preparations are produced, verified, and released in accordance with applicable federal and state pharmacy regulations, USP standards, company policies, prescriptions, formulations, and established quality procedures.

This position provides direct oversight of compounding personnel and workflow and serves as the pharmacist responsible for the final review and release of compounded preparations before they proceed to fulfillment and dispensing.

The ideal candidate has strong knowledge of sterile and/or non-sterile compounding, quality assurance, formulation review, documentation, and regulatory compliance within a 503A compounding pharmacy environment.

Essential Duties and Responsibilities

Compounding Room Oversight

• Provide pharmacist oversight of daily sterile and/or non-sterile compounding operations.
• Supervise and support compounding technicians and other authorized compounding personnel.
• Ensure compounded preparations are prepared according to approved master formulation records, prescriptions, standard operating procedures, and applicable USP requirements.
• Monitor workflow, production priorities, staffing, and workload within the compounding department.
• Verify that appropriate ingredients, components, equipment, supplies, and documentation are available before compounding begins.
• Ensure personnel follow proper garbing, hand hygiene, aseptic technique, cleaning, sanitation, and contamination-control procedures when applicable.
• Identify workflow or quality concerns and stop compounding activities when patient safety, product quality, or regulatory compliance may be compromised.
• Assist with training and competency assessment of compounding personnel.
• Promote a culture of accuracy, accountability, cleanliness, patient safety, and continuous quality improvement.

Final Verification and Product Release

• Perform final pharmacist verification of compounded preparations prior to release.
• Confirm the compounded preparation matches the patient-specific prescription and approved formulation.
• Verify calculations, ingredients, concentrations, quantities, dosage forms, routes of administration, and labeling for accuracy.
• Review compounding records and required documentation for completeness before releasing product.
• Verify appropriate beyond-use dating, storage conditions, auxiliary labeling, and packaging.
• Conduct or confirm required visual inspection of compounded preparations when applicable.
• Confirm that required in-process checks, pharmacist checks, testing, or quality-control requirements have been completed before product release.
• Place preparations on hold when discrepancies, documentation issues, quality concerns, testing failures, or other deviations are identified.
• Approve product for release only when all applicable requirements have been satisfied.
• Document pharmacist verification and release according to company procedures.

Quality Assurance and Compliance

• Maintain compliance with applicable requirements governing 503A pharmacy compounding.
• Support compliance with applicable USP standards, including USP <795>, USP <797>, and USP <800>, as applicable to pharmacy operations.
• Ensure compounded preparations are produced pursuant to appropriate patient-specific prescription requirements and company procedures.
• Review compounding documentation for completeness, accuracy, traceability, and compliance.
• Participate in investigations involving compounding errors, deviations, complaints, adverse events, or quality concerns.
• Assist with corrective and preventive actions when deficiencies are identified.
• Ensure ingredients and bulk drug substances used for compounding meet applicable requirements and pharmacy policies.
• Participate in environmental monitoring, cleaning documentation review, equipment qualification, calibration, certification, and other quality activities when applicable.
• Assist with preparation for inspections and audits conducted by regulatory agencies, boards of pharmacy, accreditation organizations, or internal quality teams.
• Maintain knowledge of changes to pharmacy laws, regulations, USP standards, and company procedures that affect compounding operations.

Documentation and Record Review

• Review and approve compounding records as required.
• Ensure appropriate lot numbers, expiration dates, quantities, calculations, and ingredient information are documented.
• Verify traceability of ingredients and components used in compounded preparations.
• Ensure discrepancies and deviations are properly documented and escalated.
• Maintain accurate pharmacist verification and release records.
• Assist with development and revision of standard operating procedures, compounding procedures, and quality documentation.

Team Leadership

• Provide guidance, coaching, and technical support to compounding technicians.
• Reinforce adherence to established policies, procedures, and quality standards.
• Assist management with identifying training needs and performance concerns.
• Participate in onboarding and competency development for new compounding employees.
• Collaborate with pharmacists, technicians, quality personnel, fulfillment personnel, customer service, and pharmacy leadership to maintain an efficient workflow.
• Escalate operational, staffing, regulatory, or patient-safety concerns to pharmacy leadership as appropriate.

Minimum Qualifications

• Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited school of pharmacy.
• Active pharmacist license in good standing in the state(s) required by the pharmacy.
• Must be IV Certified
• Experience working in a compounding pharmacy environment preferred.
• Knowledge of 503A pharmacy compounding requirements.
• Knowledge of applicable USP compounding standards, including USP <795>, <797>, and <800>, as applicable.
• Strong understanding of pharmacy calculations, formulations, labeling, documentation, and final product verification.
• Ability to identify and resolve discrepancies before compounded preparations are released.
• Strong attention to detail and commitment to patient safety and product quality.
• Strong written and verbal communication skills.
• Ability to effectively supervise, coach, and collaborate with pharmacy technicians and other team members.

Preferred Qualifications

• Previous experience in a 503A compounding pharmacy.
• Previous sterile compounding experience.
• Experience overseeing a compounding cleanroom or compounding department.
• Experience performing final verification and release of sterile and/or non-sterile compounded preparations.
• Familiarity with environmental monitoring and controlled pharmacy environments.
• Experience with peptides, hormone replacement therapies, testosterone replacement therapies, or other customized compounded medications.
• Experience participating in Board of Pharmacy, accreditation, or regulatory inspections.
• Experience developing or implementing pharmacy SOPs and quality-improvement processes.

Knowledge, Skills, and Abilities

• Excellent attention to detail.
• Strong clinical and pharmaceutical judgment.
• Strong knowledge of compounding calculations and techniques.
• Ability to recognize potential medication, formulation, labeling, and compounding errors.
• Ability to prioritize production and verification responsibilities in a fast-paced environment.
• Ability to maintain accurate and complete records.
• Ability to make independent pharmacist decisions regarding product quality and release.
• Strong leadership and problem-solving abilities.
• Ability to communicate professionally across pharmacy departments.
• Commitment to regulatory compliance, quality assurance, and patient safety.

Physical Requirements

• Ability to stand for extended periods.
• Ability to work within controlled pharmacy and compounding environments.
• Ability to wear required personal protective equipment and garb.
• Ability to perform repetitive tasks requiring accuracy and attention to detail.
• Ability to lift and move pharmacy supplies and materials consistent with job requirements.

Performance Expectations

The 503A Compounding Pharmacist is expected to ensure that no compounded preparation is released until the pharmacist has confirmed that the preparation, documentation, labeling, and applicable quality requirements are acceptable. The pharmacist must promptly identify, document, and escalate any condition that could affect product quality, regulatory compliance, or patient safety.

Disclaimer

This job description is intended to describe the general nature and level of work performed in this position. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Responsibilities may be modified based on operational needs and applicable federal, state, Board of Pharmacy, and professional practice requirements.

Second shift. Monday through Friday

2:00 pm to 10:30 pm