Scientist III Microbiologist - FSP

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 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. 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. Our proven track record spans 40 years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™