Quality Control Analyst

Position Summary

The Quality Control Analyst is responsible for supporting microbiological and quality control testing activities, environmental monitoring, and cleanroom operations within a sterile compounding environment. This role executes routine microbiological testing, performs environmental and personnel monitoring, and ensures accurate documentation and data integrity in accordance with internal procedures and regulatory requirements.

The QC Analyst will also support sample preparation, coordination, and data review for assays such as potency and other analytical methods. The QC Analyst is expected to demonstrate a foundational understanding of both microbiological and analytical (chemistry) testing to support overall product quality.

Key Responsibilities

• Perform and interpret microbiological and analytical testing activities, including but not limited to sterility, endotoxin, growth promotion, microbial identification, potency, and pH
• Operate laboratory instrumentation and ensure accurate interpretation and documentation of analytical test results in accordance with established procedures
• Perform raw material (API) sampling and ensure proper chain of custody for all samples
• Perform, document, and interpret biological indicator incubation results to support sterilization monitoring
• Conduct environmental and personnel monitoring (i.e., viable air, non-viable air, surface, and swab sampling) in classified cleanroom environments
• Execute temperature, humidity, and differential pressure monitoring for controlled environments
• Assist with incubation, tracking, and documentation of microbiological samples in accordance with SOPs
• Support stability program activities, including sample management and coordination of testing
• Maintain laboratory equipment and ensure proper operation
• Complete, review, and maintain QC documentation, logbooks, and data records with accuracy and compliance
• Investigate or support investigations of out-of-specification (OOS) results, environmental excursions, and nonconformances
• Identify and assess quality risks in processes and escalate issues as needed
• Assist in trending environmental monitoring data and identifying potential contamination risks
• Support development, revision, and adherence to SOPs, protocols, and quality documentation
• Collaborate with QA, Production, and Facilities to support contamination control and timely batch release
• Perform other duties as assigned to support departmental goals, operational needs, and regulatory compliance

Required Qualifications

• Associate’s degree with relevant experience in a cGMP, GLP, or regulated laboratory environment.
• 3+ years of experience in a pharmaceutical, biotech, or compounding environment
• Experience with aseptic technique and cleanroom gowning
• Working knowledge of microbiological principles, aseptic technique, and contamination control
• Foundational understanding of analytical chemistry concepts, including sample preparation, laboratory instrumentation, and interpretation of analytical data
• Familiarity with cGMP/GLP documentation practice.
• Understanding of environmental and personnel monitoring programs
• Ability to follow and execute SOPs, protocols, and regulatory requirements
• Strong attention to detail with good organization and documentation practices
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook)
• Ability to interpret data and communicate results clearly
• Self-motivated and able to manage multiple tasks in a fast-paced environment
• Strong interpersonal, verbal, and written communication skills

Preferred Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific field
• Experience with analytical chemistry methods (i.e., potency testing, HPLC, or similar)

Work Environment & Physical Requirements

• Primarily a controlled environment (ISO 5–8) and general office or laboratory spaces
• Frequent standing, walking, and use of hands
• Ability to lift up to 25 lbs
• Manual dexterity for handling small components and materials
• Use of PPE, sterile gowning, and adherence to strict contamination control protocols
• No makeup, perfume, fake or long nails, or fake eyelashes
• Schedule: Able to work flexible schedules and occasional weekends or holidays based on production needs

Featured Benefits  

• Competitive salary
• Comprehensive health, dental, and vision insurance
• 401k with employer match
• Paid Time Off
• Employee Perks & Discounts