Offsite Environmental Monitoring Technician
Required skills
- Environmental Monitoring
- FDA
- cGMP
- SOPs
- Air Viable
- Surface Viable
- Air Nonviable
- Compressed Gas
- Purified Water
- Bioburden
Nice to have
- Associate's Degree
- Science Classes
- cGMP Experience
Role summary
The Offsite Environmental Monitoring Technician performs daily Environmental Monitoring (EM) of pharmaceutical cleanrooms and associated spaces, adhering to FDA, cGMP, and client Standard Operating Procedures. The role involves collecting various EM samples (air viable, surface viable, air nonviable), compressed gas samples, and purified water samples for analysis. Responsibilities include accurate documentation, timely sample delivery to the client lab, and strict adherence to methodologies. The position requires flexibility, weekend work, and basic computer skills, with a preference for science classes or an associate's degree and cGMP experience.
JOB SUMMARY
The Offsite Environmental Monitoring Technician will perform Environmental Monitoring (EM) of pharmaceutical cleanrooms and the associated spaces on a daily basis according to FDA, cGMP and BA Science’s/Client Standard Operating Procedures. The position is primarily in the Morrisville, NC area but will vary depending on client location.
PRIMARY DUTIES AND RESPONSIBILITIES
- Collects routine daily, weekly and monthly EM samples in a variety of pharmaceutical cleanrooms. Sample types include but are not limited to air viable, surface viable, and air nonviable monitoring.
- Collects compressed gas samples to ensure they are free of microbial and chemical contamination.
- Samples purified water system at both generation and point of use for subsequent analysis for Bioburden, TOC, Conductivity, and Endotoxin.
- Clearly documents sample collection activities according to client requirements.
- Promptly delivers the associated collected samples to the onsite client lab for analysis.
- Performs assigned sampling tasks carefully and on schedule according to standard operating procedure and supervisor instruction.
- Ensures all work performed strictly adheres to cGMP, company, client and pharmacopeial methodologies.
- Participates in company sponsored training.
- Maintains productive work ethic.
REQUIREMENTS AND QUALIFICATIONS
A high school diploma or GED is required. Science classes or an associate’s degree in a scientific discipline is preferred. An Offsite Environmental Monitoring Technician should be willing to attend technical training classes to enhance skills or correct identified deficiencies. There is no minimal related work experience required. Weekend work is required. Flexibility regarding shift work is required depending on business need.
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)
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