Quality Analyst

TMC Acquisition LLC•Nicholasville, KY

12d

About The Position

Tailor Made Compounding, established in 2016, has quickly grown into one of the nation’s leading 503A compounding pharmacies—recognized for our commitment to quality, precision, and patient safety. As a fast-growing organization operating in a highly regulated environment, we rely on strong quality systems and disciplined execution to support sterile compounding operations that meet the highest standards. To support our continued growth and commitment to excellence, we are seeking a Quality Analyst to join our Quality team. Summary The Q uality Analyst will perform routine environmental sampling and support contamination control within the sterile pharmaceutical compounding cleanroom facilities. This role is essential in ensuring a controlled environment for aseptic operations and maintaining compliance with USP <797>, USP <800>, and 503A regulatory standards. The Q uality Analyst will be responsible for executing all aspects of the environmental monitoring program, including sample collection, incubation, documentation, reporting, and assisting in microbial investigations and laboratory submissions . The Q uality Analyst will also be involved in other quality related activities. This position reports to the Senior Quality Specialist .

Requirements

College degree in a science discipline is preferred.
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 writ ing technical report s and trend docu ments.
Successful completion or ability to pass initial and ongoing garbing evaluations.
Strong attention to detail and commitment to aseptic technique and contamination control.
S kill/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 .

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 .