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

Parexel

4d•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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. 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!

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)

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.