Quality Assurance Specialist

Lowtide Pharmacy LLC; Atlanta (GA); On-site; USD 60,000 - 85,000; Full time

Job summary

Lowtide Pharmacy LLC is seeking a detail-oriented Quality Assurance (QA) Specialist to support the QA program and help ensure compliance with USP <797> standards, state Board of Pharmacy requirements, company policies, and 503A pharmacy requirements. You will work with the PIC, pharmacists, technicians and leadership to maintain documentation and monitor quality processes.

The role emphasizes audits, CAPA, training, deviation investigation, and preparation for inspections, with a focus on

Qualifications

• 2+ years of experience in pharmacy, healthcare, quality assurance, or related field.
• Compounding pharmacy experience strongly preferred.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to identify problems and follow through with corrective actions.
• Ability to maintain accurate records and documentation.

Responsibilities

• Maintain and support the pharmacy's Quality Assurance Program.
• Conduct routine audits of compounding records and quality logs.
• Monitor and ensure compliance with USP 795/797 requirements.
• Review environmental monitoring, cleaning, temperature, equipment, and calibration records.
• Assist with CAPA and root-cause analysis.
• Prepare for regulatory inspections and maintain inspection-ready QA records.
• Document and investigate deviations and complaints.
• Support training and competency assessments.

Skills

Detail-oriented

Organizational skills

Excellent communication

Independent worker

Team collaboration

Job description

Lowtide Pharmacy is seeking a detail-oriented and dependable Quality Assurance (QA) Specialist to support the pharmacy's quality assurance program and help ensure compliance with applicable USP<797> standards, state Board of Pharmacy requirements, company policies, and 503A pharmacy requirements.

The QA Specialist will work closely with the Pharmacist-in-Charge (PIC), pharmacists, technicians, and pharmacy leadership to maintain accurate documentation, monitor quality processes, identify potential issues, and support continuous improvement.

Key Responsibilities

• Maintain and support the pharmacy's Quality Assurance Program.
• Conduct routine audits of compounding records, documentation, logs, and quality records.
• Knowledge of USP <795> and/or USP <797>.
• Monitor compliance with applicable USP <795> and/or USP <797> requirements.
• Review environmental monitoring, cleaning, temperature, equipment, and calibration records as applicable.
• Maintain and monitor SOPs, training records, and competency documentation.
• Assist with personnel training and competency assessments.
• Document and investigate deviations, errors, complaints, and other quality events.
• Assist with root-cause analysis and corrective and preventive actions (CAPA).
• Monitor quality trends and report significant concerns to the PIC and pharmacy leadership.
• Assist with product complaint investigations, recalls, and mock recalls.
• Maintain organized, inspection-ready QA records.
• Assist with preparation for Board of Pharmacy and other regulatory inspections.
• Work with pharmacy staff to identify opportunities for process improvement.
• Maintain confidentiality of patient, employee, pharmacy, and business information.
• Immediately escalating any quality issue that may affect patient safety.

Qualifications

• 2+ years of experience in pharmacy, healthcare, quality assurance, laboratory, or a related field preferred.
• Compounding pharmacy experience strongly preferred.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to identify problems and follow through with corrective actions.
• Comfortable reviewing documentation and maintaining accurate records.
• Ability to work independently while collaborating with pharmacy staff.
• Strong sense of accountability, integrity, and confidentiality.