Tailor Made Compounding · 9 hours ago
Quality Analyst
Nicholasville, Kentucky, United States
Full-time
Onsite
Entry Level
$22/hr - $27/hr
1+ years expTailor Made Compounding is a leading 503A compounding pharmacy committed to quality and patient safety. They are seeking a Quality Analyst to perform environmental sampling and support contamination control within sterile compounding cleanroom facilities, ensuring compliance with regulatory standards.
BiotechnologyHealth Care
Responsibilities
Perform routine viable air sampling, surface sampling, and personnel monitoring sampling within ISO-classified cleanroom environments
Adhere to defined sampling schedules and respond to unscheduled or investigative sampling needs
Document sampling events, locations, results, and observations in compliance with internal SOPs and regulatory expectations
Manage the proper incubation of solid and liquid microbiological media at appropriate temperature conditions (e.g., 20–25°C and 30–35°C)
Perform interim and final readings of:
Media plates
Biological indicators
Media fill samples
Report and investigate results at alert and/or action levels
Coordinate submission of applicable samples to third-party laboratories and assist in investigation data gathering
Contribute to root cause analysis and corrective action activities
Create environmental trend reports for classified areas
Review continuous monitoring of the classified areas/equipment and alert management to excursions
Submit products for required testing to third party labs and review of testing results upon completion
Other duties as assigned
Qualification
Required
Minimum 1 year of experience in one or more of the following: Viable air sampling using impaction, Surface sampling using contact plates, Personnel aseptic technique sampling, Plate enumeration
Ability to work in sterile garb for extended periods within an ISO Class 5 environment
Experience writing technical reports and trend documents
Successful completion or ability to pass initial and ongoing garbing evaluations
Strong attention to detail and commitment to aseptic technique and contamination control
Skill/experience in the Microsoft Office: Word and Excel
Strong time management skills
Excellent organizational skills and multitasking ability
Excellent interpersonal skills and the ability to work well in a team environment
Preferred
College degree in a science discipline
Company
Tailor Made Compounding
Compounding Pharmacy
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Blake McLeod
Chief Operating Officer
Joshua Jones, PMP, CSSBB
Chief Information Officer
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