Quality Control Microbiologist

Primary Duties and Responsibilities

• Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, Sterility, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).
• Documents work in a clear and organized manner.
• Revises procedures and ELNs under close supervision.
• Follows all safety rules and regulations and conducts periodic safety audits.
• Follows all cGMP rules and regulations.
• Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.
• Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.
• Performs routine data generation and problem solving with a minimal rework.
• Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
• Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
• Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
• Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

Requirements

Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred. 

Minimum Skills Requirements

• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
• A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
• Must have excellent organizational, verbal communication and technical documentation skills.
• Solid computer skills.
• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.