Microbiologist I, QC

Job Description

Job Description

Salary:

JOB SUMMARY
The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical
products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.
Duties will include analysis of pharmaceutical products through compendial methods and client
specific test protocols.

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
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 member