Quality Control Analyst (Microbiologist)

Job Description

Job Description

Description:

Job Purpose

The Microbiologist is responsible for performing microbiological testing of raw materials, water, environmental monitoring samples, in-process materials, and finished dosage forms in compliance with current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP), FDA regulations, and Mikart Standard Operating Procedures (SOPs). This position supports product quality, regulatory compliance, and laboratory operations through accurate testing, documentation, and continuous improvement initiatives.

Essential Job Functions

• Receive incoming samples, including water, environmental, raw material, and finished dosage form samples, ensuring all information is accurately and promptly documented in laboratory logs and tracking systems.
• Perform microbiological and other required laboratory testing safely and in accordance with cGMP, USP, FDA, and Mikart specifications, procedures, and test methods.
• Immediately report any discrepancy, suspect, atypical, or out-of-specification (OOS) results to the Microbiology Supervisor and accurately execute investigation plans as directed.
• Generate, review, and revise microbiological test specifications, methods, and procedures as needed. Assist in reviewing applicable USP chapters and regulatory requirements and implement required procedural updates.
• Ensure proper handling, labeling, storage, and disposition of all samples, including controlled substances, while maintaining chain of custody and sample integrity.
• Process laboratory waste in accordance with established procedures and environmental, health, and safety regulations.
• Participate in equipment installation, qualification, calibration, maintenance, and performance verification activities.
• Assist in developing, reviewing, and maintaining Standard Operating Procedures (SOPs), test methods, and laboratory documentation for microbiology operations and equipment.
• Accurately complete equipment usage logs, maintenance records, calibration documentation, and laboratory notebooks in a timely manner.
• Maintain laboratory cleanliness and organization while ensuring compliance with aseptic techniques and contamination control practices.
• Participate in internal audits, regulatory inspections, laboratory investigations, and continuous improvement initiatives.
• Support special projects and perform other duties as assigned.

Key Characteristics

• The individual selected for the role as an Analyst must be independent and will be required to get tasks completed on time by being detail-oriented, organized and methodical.
• Team Player.
• Reliable, self-starting, and organized.
• Able to follow clear instructions.
• Attention to detail.
• Consistent completion of assignments with minimal errors.
• Robust Communication skills (oral and written)
• Flexible work hours.

Education and Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life science required.
• Minimum of 1–3 years of microbiology laboratory experience in a pharmaceutical, biotechnology, or regulated manufacturing environment preferred.
• Experience working in a cGMP laboratory environment is highly desirable.
• Knowledge of USP microbiological testing requirements, FDA regulations, and aseptic laboratory techniques.
• Experience performing environmental monitoring, water testing, microbial limits testing, sterility testing, and identification of microorganisms is preferred.
• Proficiency with Microsoft Office applications and laboratory documentation systems.

Physical Demands

• Ability to stand and walk for extended periods.
• Frequent use of laboratory equipment requiring manual dexterity.
• Ability to lift up to 25 pounds.
• Ability to wear required personal protective equipment (PPE), including laboratory coats, gloves, eye protection, and other safety equipment.
• Ability to work in laboratory environments involving biological materials, chemicals, and controlled substances while following all safety procedures.