Scientist III Microbiologist - FSP
PAREXEL, Harrisburg, PA, United States
We are looking to fill a microbiologist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off.
This position does not offer any sponsorship.
Qualifications
Bachelor's degree required; concentration in a scientific or applied discipline strongly preferred, with 3-5 years of experience in pharmaceutical microbiology related position required; or a MS with 1-2 years of experience
Required Skills and Experience
Solid microbiology foundation with experience in performing product testing
Proven technical writing skills (SOPs, protocols)
Desired Skills and Experience
Experience in the pharmaceutical/biotechnology industries preferred
Experience with environmental monitoring and water testing preferred
Responsibilities
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
MICROBIOLOGICAL ACTIVITIES Include (but not limited to):
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
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
PROCAL Entries
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 hours 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.
This position does not offer any sponsorship.
Qualifications
Bachelor's degree required; concentration in a scientific or applied discipline strongly preferred, with 3-5 years of experience in pharmaceutical microbiology related position required; or a MS with 1-2 years of experience
Required Skills and Experience
Solid microbiology foundation with experience in performing product testing
Proven technical writing skills (SOPs, protocols)
Desired Skills and Experience
Experience in the pharmaceutical/biotechnology industries preferred
Experience with environmental monitoring and water testing preferred
Responsibilities
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
MICROBIOLOGICAL ACTIVITIES Include (but not limited to):
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
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
PROCAL Entries
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 hours 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.