About the Role
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 escalate any quality issue that may affect patient safety.
Preferred Skills
503A compounding pharmacy.
Sterile and/or nonsterile compounding.
Environmental monitoring.
QA audits.
CAPA and root-cause investigations.
SOP development and document control.
Pharmacy inspections.
Education and 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.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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