Quality Control Technician (Sun-Wednesday 9PM to 7AM)

About the role

The Quality Control (QC) Technician will be responsible for ensuring the safety and quality of the compounding sterile environment in a 503A pharmacy by performing environmental monitoring, sample collection, conducting quality tests sample submissions (sterility, endotoxin, potency) and maintaining accurate documentation per USP standards.

Responsibilities

• Environmental Monitoring: Perform routine environmental monitoring of cleanrooms and other controlled areas, including air and surface sampling for microbial contamination, to ensure compliance with USP standards.
• Quality Testing: Conduct quality control tests on compounded sterile preparations, including sterility, endotoxin, potency, and pH testing, as applicable.
• Documentation and Compliance: Maintain accurate and detailed records of QC activities, including test results, environmental monitoring data, and equipment calibration logs, ensuring compliance with regulatory requirements.
• Equipment Maintenance: Calibrate, clean, and maintain laboratory equipment used in QC testing, such as laminar airflow hoods, incubators, and analytical instruments.
• SOP Adherence: Follow and enforce Standard Operating Procedures (SOPs) for compounding, testing, and cleaning processes to ensure consistency and compliance.
• Investigations and CAPA: Assist in investigating out-of-specification (OOS) results, deviations, or non-conformances, and support the development and implementation of Corrective and Preventive Actions (CAPA).
• Training Support: Assist in training pharmacy staff on proper aseptic techniques, gowning procedures, and compliance with USP standards.
• Inventory Management: Monitor and maintain inventory of QC testing supplies, reagents, and media, ensuring availability and proper storage conditions.
• Collaboration: Work closely with pharmacists, compounding technicians, and quality assurance (QA) staff to ensure seamless operations and adherence to quality standards.
• Regulatory Preparedness: Support preparation for inspections by state boards of pharmacy, FDA, or other regulatory bodies, ensuring all QC documentation and processes are audit-ready.

Qualifications

• High school diploma or equivalent required.
• Minimum of 1 year of experience in a sterile compounding pharmacy, microbiology laboratory, or related field.
• Experience with USP and USP guidelines, cGMP principles, and state/federal pharmacy regulations.
• Strong attention to detail and ability to follow complex protocols.
• Experience in aseptic techniques and cleanroom operations.
• Basic understanding of microbiology and analytical testing methods.
• Excellent documentation and organizational skills.
• Ability to work independently and collaboratively in a team environment.
• Strong communication skills, both written and verbal.
• Minimum of 2 years of experience with Microsoft Office (e.g., Excel, Word, Google Sheets, GoogleDocs) for documentation and reporting.

Preferred Qualifications

• Associate’s or Bachelor’s degree in a science-related field (e.g., biology, microbiology, chemistry).
• Experience in a 503A or 503B pharmacy quality control experience.
• Laboratory experience and Good Laboratory Practices (GLP).
• Certification as a Pharmacy Technician (CPhT) Texas issued

Physical Requirements

Ability to stand for extended periods, wear personal protective equipment (PPE), and work in a controlled cleanroom environment.

Sunday - Wednesday (9PM to 7AM)