Quality Control Technician
About The Position
The Quality Control Technician Lead will be responsible for ensuring the safety and quality of the sterile compounding environment in a 503A pharmacy by performing environmental monitoring, sample management, conducting quality testing, and maintaining accurate documentation in compliance with USP <797> standards. This role provides technical oversight while ensuring consistency in execution of environmental monitoring, documentation, and quality processes across shifts. We are currently hiring for two full-time positions aligned to the same shift hours (7:00 AM - 3:00 PM) with different weekly schedules: Tuesday through Saturday, and Sunday through Thursday.
Requirements
- High school diploma or equivalent
- Minimum of 1 year of experience in a sterile compounding pharmacy, microbiology lab, or related field
- Experience with USP <797> and USP <800> guidelines, cGMP principles, and 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
- Strong documentation and organizational skills
- Ability to work both independently and collaboratively
- Strong written and verbal communication skills
- Minimum of 2 years of experience with Microsoft Office (Excel, Word, Google Sheets, Google Docs)
Nice To Haves
- Prior experience in a QC or sterile operations role within a cleanroom environment
- Associate’s or Bachelor’s degree in a science-related field (biology, microbiology, chemistry)
- Experience in a 503A or 503B pharmacy environment
- Familiarity with Good Laboratory Practices (GLP)
- Experience supporting investigations, deviations, or regulatory inspections
Responsibilities
- Identify potential quality risks in real time and initiate appropriate notifications or containment actions
- Ensure deviations, data integrity concerns, or incomplete documentation are identified promptly and escalated appropriately
- Ensure consistency in environmental monitoring practices, incubation handling, plate labeling, and documentation across shifts
- Participate in real-time coordination with Sterile leadership regarding sampling timing and cleanroom readiness
- Perform routine environmental monitoring of cleanrooms and controlled areas, including air and surface sampling for microbial contamination in compliance with USP <797>
- Conduct quality control testing on compounded sterile preparations, including sterility, endotoxin, potency, and pH testing
- Maintain accurate and detailed records of QC activities, including environmental monitoring data, test results, and calibration logs
- Calibrate, clean, and maintain laboratory equipment such as laminar airflow hoods, incubators, and analytical instruments
- Follow and enforce Standard Operating Procedures (SOPs) for compounding, testing, and cleaning processes
- Assist in investigations of deviations, OOS results, and non-conformances while supporting CAPA implementation
- Support training of pharmacy staff on aseptic technique, gowning, and USP <797> compliance
- Monitor and maintain inventory of QC supplies, reagents, and media
- Collaborate with pharmacists, compounding technicians, and QA teams to ensure quality alignment
- Support inspection readiness for regulatory bodies including FDA and state boards of pharmacy
Benefits
- Full benefits package including medical, dental, vision, and paid time off
- Supportive environment with opportunities for professional growth and training
- Full-time schedule
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
1-10 employees
