Company Overview:

Southend Pharmacy specializes in compounding weight loss medications, including Semaglutide and Tirzepatide, for providers across the USA. Join the ranks of satisfied healthcare professionals who trust Southend Pharmacy for unmatched quality, speed, and care that makes a real difference in patient health—let’s raise the bar together.

About the Role:

The Quality Control (QC) Technician will be responsible for but not limited to 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 <797> standards.

Key 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 <797> 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 <797> 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.

Required Qualifications:

• High school diploma or equivalent required.
• Minimum of 1 years of experience in a sterile compounding pharmacy, microbiology laboratory, or related field.
• Experience with USP <797> and USP <800> 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:

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