QA Specialist

Top Quality Recruitment (TQR); Oxford (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

Top Quality Recruitment (TQR) seeks a Quality Assurance Specialist for a pharmacy client in Georgia. The role supports the QA program, ensures compliance with USP 795/797, state Boards, and 503A standards, and collaborates across teams to keep inspection-ready records.

You will conduct audits, review records, assist with CAPA, training, and regulatory preparations, and help drive process improvements while protecting patient safety and confidentiality.

Qualifications

• 2+ years of experience in pharmacy, healthcare, quality assurance, laboratory, or a related field.
• Compounding pharmacy experience strongly preferred.
• Strong attention to detail and organizational skills.

Responsibilities

• Maintain and support the pharmacy's Quality Assurance Program.
• Conduct routine audits of compounding records, documentation, logs, and quality records.
• 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.
• 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 escape any quality issue that may affect patient safety.

Skills

Sterile and nonsterile compounding

CAPA investigations

SOP development

Pharmacy inspections

Job description

The Quality Assurance Specialist will 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.

Key Activities

• 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
• 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 escape any quality issue that may affect patient safety.

Preferred Skills

• Sterile and/or nonsterile compounding.
• CAPA and root-cause investigations.
• SOP development and document control.
• Pharmacy inspections.

Educations & Experience

• 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.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.