QA Specialist

Top Quality Recruitment (TQR); Oxford (GA); On-site; USD 55,000 - 85,000; Full time

Job summary

Top Quality Recruitment (TQR) is seeking a Quality Assurance Specialist to support the pharmacy's QA program and ensure compliance with USP 797 standards, state Board of Pharmacy requirements, and 503A pharmacy rules.

You will conduct audits of records, monitor CAPA, prepare for inspections, and work with staff to improve processes while maintaining confidential records and patient safety.

Qualifications

• 2+ years of experience in pharmacy, healthcare, quality assurance, or related field preferred.
• 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.
• Review deviations, errors, complaints, and other quality events; document investigations.

Skills

Attention to detail

Regulatory compliance

USP 795/797 knowledge

Audit and CAPA

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.