Scientist 2-Microbiologist

Parexel International Corporation

Multiple Locations

We are looking to fill a Scientist 2 position working as a full-time employee of ExecuPharm / 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. If interested, please send an electronic copy of your resume to [email protected] . This position does not offer any sponsorship.

QualificationsBachelor’s degree required; concentration in a scientific or applied discipline strongly preferredA minimum of 1-2 years of experience in a related role required (occasional overtime)

Required Skills and ExperienceSolid microbiology foundation with experience in performing product testingProven technical writing skills (SOPs, protocols)

Desired Skills and ExperienceExperience in the pharmaceutical/biotechnology industries preferredExperience with GMP preferred

Responsibilities

MICROBIOLOGICAL PRODUCT ANALYSIS Analyze samples and compile meaningful dataPerform Investigations and prepare/respond to CAPAsReview, revise Test Procedures/Standard Operating ProceduresAd Hoc work

MICROBIOLOGICAL ACTIVITIES Include (but not limited to):Receive, verify & Log in samplesMicrobial testing: including Bioburden, Endotoxin, Microbial Examination, Sterility, AME, Growth PromotionStock culture management and quality control of sameMedia management: reciept and quality control release of MediaData review and reportingPrepare and ship materials offsite for ID/testing (when applicable)Gowning activities and cleaning graded room.Research experiments as deemed appropriate by Merck managementMethod Verifications

CALIBRATIONS:Execute “Before-Use” calibrations prior to performing testingReview calibration data within the ELNPrepare and submit equipment for calibrations (offsite or onsite)Complete calibration/PM paperwork

GMP ACTIVITIES:Prepare GMP documentation as requested by managementPerform laboratory sanitizations and ensure cleanliness of laboratory workspacePerform equipment sanitizations (incubators / hoods / refrigerators)Purchase supplies (GMP)Weekly lab maintenance activitiesPrepare equipment for autoclave sterilization

INVESTIGATIONS:Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) forInform management of non-conforming events

AUDITS:Participate in audits (Regulatory, In-house, Corporate)Participate in self-inspections and safety inspectionsRetrieve data when requested by Microbiology management

TRAINING:Complete assigned training when requiredEnsure training is complete prior to performing tasks

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP, which 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!


2022-09-17 00:05:20


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