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Microbiological Quality Control Analyst
2 months ago
Position Summary:
The Microbiological Quality Control Analyst is responsible for performing both quantitative and qualitative assessments of pharmaceutical products in accordance with FDA regulations, cGMP standards, and the protocols established by Boston Analytical, Inc. This role involves the analysis of pharmaceutical products utilizing both compendial methodologies and specific client testing protocols.
Key Responsibilities:
- Conducts sample preparation and analysis to evaluate microbiological quality through various tests, including microbial enumeration, sterility testing, endotoxin testing, and water quality assessments (bioburden, TOC, Conductivity).
- Maintains clear and organized documentation of all work performed.
- Assists in the revision of procedures and electronic laboratory notebooks under direct supervision.
- Adheres to all safety protocols and participates in regular safety audits.
- Complies with all cGMP regulations and guidelines.
- Collaborates with Microbiologists and other personnel to discuss research findings, methodologies, and results, while preparing comprehensive reports.
- Receives training under close supervision to develop proficiency in assigned tasks, aiming to become a subject matter expert.
- Engages in routine data generation and problem-solving with minimal need for rework.
- Operates under close supervision to ensure compliance with standard operating procedures, good manufacturing practices, and FDA regulations.
- Ensures strict adherence to company, client, and Pharmacopeial methodologies in all work conducted.
- Conducts maintenance and calibration of systems to ensure equipment operates within specified parameters.
- Handles hazardous waste responsibly, in accordance with company and regulatory guidelines.
Qualifications:
A Bachelor’s degree in Microbiology or a related scientific discipline is required, along with 0-2 years of relevant experience. Familiarity with cGMP and compliance regulations is preferred.
