Microbiologist, EM

Boston Analytical; Morrisville (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

BA Sciences is seeking a Microbiologist, Environmental Monitoring to support microbiological testing and EM programs for pharmaceutical clients.

Responsibilities include bioburden, TOC, endotoxin analyses, off-site monitoring, and meticulous data documentation in LIMS and GDocP, with travel to client sites as required.

Qualifications

• Bachelor’s degree in microbiology, biology, or related life science field; 0-3 years in pharma lab.
• Knowledge of GMP and aseptic techniques; experience in environmental monitoring preferred.
• Strong documentation and data integrity practices.

Responsibilities

• Perform environmental monitoring of cleanrooms and controlled environments, including air and surface sampling.
• Conduct microbiological analyses such as bioburden, growth promotion, TOC, and endotoxin.
• Incubate, enumerate, and identify microbial isolates with standard techniques.
• Author/review OOS investigations, deviations, and corrective actions.
• Document data through GDocP and LIMS procedures, both on paper and electronic systems.
• Maintain aseptic practices in lab and client cleanrooms.
• Handle, store, and dispose of hazardous materials per OSHA and company procedures.
• Ensure work adheres to cGMP, methodologies, and client requirements.
• Travel to off-site client locations as needed.

Skills

GMP knowledge

Aseptic techniques

Documentation

Data integrity

Interdepartmental collaboration

Education

Bachelor’s degree in microbiology

Tools

LIMS

GDocP

Job description

JOB SUMMARY

The Microbiologist, Environmental Monitoring (EM) will be responsible for supporting microbiological testing and environmental monitoring programs for pharmaceutical clients. This role will conduct microbial analysis such as but not limited to bioburden, growth promotion, Total Organic Carbon (TOC), and endotoxin. In addition, the job is required to perform off-site environmental monitoring for external clients. All testing and sampling must be according to FDA,cGMPand BA Science’s Standard Operating Procedures.

PRIMARY DUTIES AND RESPONSIBILITIES

• Perform environmental monitoring of cleanrooms and controlled environments including viable and non-viable air samples, surface sampling, and gas sampling.
• Conduct microbiological analysis such as bioburden, growth promotion, TOC, and endotoxin.
• Incubate, enumerate, and identify microbial isolates using standard microbiological techniques.
• Author and review Out-of-Specification (OOS) investigations, deviations, and corrective actions.
• Document data through GDocP and BA internal procedures, within paper records and LIMS system.
• Ensure aseptic practices in the laboratory and within client cleanroom environment.
• Cleans and maintains laboratory glassware (including sterilization), equipment, and laboratory.
• Properly handles, stores and disposes of hazardous materials according to OSHA and BA Sciences procedures.
• Ensures all work performed strictly adheres to cGMP, company, client and pharmacopeial methodologies.
• Follows all safety rules and regulations.
• Handling hazardous waste by segregating organic waste from aqueous waste and consolidating waste as directed.
• Able to travel to off-site to clients, to work independently and professionally for extended timeframes.

REQUIREMENTS AND QUALIFICATIONS

Bachelor’s degree in microbiology, biology, or related life science field. 0-3 years of experience in microbiology pharmaceutical lab environment. Knowledge of GMP experience and aseptic techniques. Experience in environmental monitoring preferred. Strong documentation and data integrity practices.

MINIMUM SKILLS REQUIREMENTS

• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
• Self-starting motivated person who possesses good interpersonal skills and who is able to effectively interact with all departments with the company.
• Must have good organizational and verbal communication skills.
• Basic computer skills required.
• Experience with cGMP is preferred.
• Must be a team player with integrity and concern for the quality of company products, services and staff members.

SHIFTS

• Wednesday-Saturday (2nd shift)
• Sunday-Wednesday (2nd shift)