Scientist III Microbiologist - FSP
Parexel, Phila, PA, United States
We are looking to fill a microbiologist position working as a full‑time employee of Parexel FSP on a long‑term assignment onsite at one of our clients in West Point, PA. This position offers full benefits, sick time, 401(k), paid holidays, and paid time off. The position does not offer any sponsorship. The role is intended to be a 40‑hour per week position.
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 and revise test procedures/standard operating procedures; perform ad‑hoc work; participate in rotational on‑call assignments.
Microbiological Activities (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 (off‑site or on‑site).
Complete calibration/PM paperwork.
PROCα 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) for Environmental samples.
Notice of Event 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.
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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 and revise test procedures/standard operating procedures; perform ad‑hoc work; participate in rotational on‑call assignments.
Microbiological Activities (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 (off‑site or on‑site).
Complete calibration/PM paperwork.
PROCα 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) for Environmental samples.
Notice of Event 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.
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