Scientist III - Microbiologist, EM Focus, Analytical Sciences Microbiology

Job Description

We are looking to fill a microbiologist position (environmental monitoring focus) working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. The role is intended to be a 40-hour-per-week position.

Job Responsibility

ENVIRONMENTAL MONITORING: Proficiency in the pharmaceutical microbiology laboratory workflow for EM collection and testing, reporting and trending
Sampling EM rooms, surface and air
Collection and testing water samples
Weekly water trends- visually to be able to report back to the source area
Equipment responsibilities with metrology oversight, automation, etc
MODA USE: Responsible for writing annual reports
Responsible for writing trend reports
Able to clearly interpret adverse vs desirable data
Mold investigations and studies
PSIM work
Biological indicator analysis and certification
Disinfection studies where appropriate
Critical thinking with data
MICROBIOLOGICAL PRODUCT ANALYSIS: Analyze samples and compile meaningful data
Perform Investigations and prepare/respond to CAPA
Review, revise Test Procedures/Standard Operating Procedures
Ad Hoc work
Rotational on-call assignments for responding to alarms
MICROBIOLOGICAL ACTIVITIES Include (but not limited to): Receive, verify & Log in samples
Return templates and shipping paperwork when and where appropriate
Prepare and ship materials offsite for ID/testing (when applicable)
Stock culture management and quality control of same
Biological indicator management
Bioburden testing
Water sampling
Microbiological media management and quality control of same
Sterilization activities
Research experiments as deemed appropriate by client management
Method Validation/Qualification
Other microbiological activities
CALIBRATIONS: Execute “Before-Use” calibrations prior to performing testing
Review calibration data within the ELN
Prepare and submit equipment for calibrations (offsite or onsite)
Complete calibration/PM paperwork
GMP ACTIVITIES: Prepare GMP documentation as requested by management
Perform laboratory sanitizations and ensure cleanliness of laboratory workspace
Perform equipment sanitizations (incubators / hoods / refrigerators)
Purchase supplies (GMP)
Prepare and send documents to Records Center
INVESTIGATIONS: Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)]
Inform management of non-conforming events
AUDITS: Participate in audits (Regulatory, In-house, Corporate)
Participate in self-inspections and safety inspections
Retrieve data when requested by Microbiology management
TRAINING: Complete assigned training when required
Ensure training is complete prior to performing tasks

Requirements

Bachelor’s degree required
concentration in a scientific or applied discipline strongly preferred
A minimum of two years of experience in pharmaceutical microbiology related position required (occasional overtime)
Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring
Proven technical writing skills (SOPs, protocols)

What we offer

full benefits
sick time
401K
paid holidays
paid time off

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Scientist III - Microbiologist, EM Focus, Analytical Sciences Microbiology - FSP

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