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

Parexel • Denver, CO • 2h ago

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.

Qualifications

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)

Required Skills and Experience

Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring

Proven technical writing skills (SOPs, protocols)

Responsibilities

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

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

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

LI-DK1

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel

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