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Parexel · 2 hours ago

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

United States - New Jersey - Client Onsite

Full-time

Onsite

Entry, Mid Level

2+ years exp

Parexel is a company dedicated to improving the world's health through clinical trials and regulatory consulting. They are seeking a Scientist III - Microbiologist with a focus on environmental monitoring to work onsite at a client location, responsible for various microbiological activities and ensuring compliance with GMP standards.

Pharmaceuticals

No H1B

Responsibilities

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

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

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

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

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

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

Participate in audits (Regulatory, In-house, Corporate)

Participate in self-inspections and safety inspections

Retrieve data when requested by Microbiology management

Complete assigned training when required

Ensure training is complete prior to performing tasks

The role is intended to be a 40-hour-per-week position

Qualification

GMP Pharmaceutical experienceEnvironmental monitoringTechnical writingMicrobiological analysisMethod ValidationCritical thinkingTeam collaboration

Required

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)

Benefits

Full benefits

Sick time

401K

Paid holidays

Paid time off

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees