Scientist III Microbiologist - FSP

Parexel

1d•Onsite

About The Position

At Parexel, the goal is to improve the world's health through clinical development solutions. This specific role is for a Scientist III Microbiologist, working as a full-time employee of Parexel FSP on a long-term assignment onsite at one of their clients in West Point, PA. The position is within the CMC Operations group, which provides qualified technical professionals to support the development and delivery of new therapies for pharmaceutical and biopharmaceutical companies. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. The company emphasizes making a meaningful difference, keeping patients at the center, and fostering an inclusive community.

Requirements

Bachelor’s degree required; concentration in a scientific or applied discipline strongly preferred
3-5 years of experience in pharmaceutical microbiology related position required (with Bachelor's degree)
MS with 1-2 years of experience (as an alternative to Bachelor's degree)
Solid microbiology foundation with experience in performing product testing
Proven technical writing skills (SOPs, protocols)

Nice To Haves

Experience in the pharmaceutical/biotechnology industries preferred
Experience with environmental monitoring and water testing preferred

Responsibilities

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
Receive, verify & Log in samples
MLT Method Suitability testing
Endotoxin testing
Return templates and shipping paperwork when and where appropriate
Compile and trend data
Prepare and ship materials offsite for ID/testing (when applicable)
Environmental monitoring
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
Rotational on-call assignments for responding to alarms
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
PROCAL Entries
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