Scientist 2-Microbiologist Analytical Science-4324

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

Requirements: Solid microbiology foundation with experience in performing product testing Proven technical writing skills (SOPs, protocols)

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

Responsibilities:

MICROBIOLOGICAL PRODUCT ANALYSIS and ENVIRONMENTAL MONITORING & TESTING Analyze samples and compile meaningful data Perform Investigations and prepare/respond to CAPA Review, revise Test Procedures/Standard Operating Procedures Ad Hoc work

MICROBIOLOGICAL ACTIVITIES Include (but not limited to) : Receive, verify & Log in samples 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 Merck management Method Validation/Qualification

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

This position requires an average of four hours per week (16 hours per month) beyond the standard 40-hour week. Compensation for this is built into the salary.

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

EEO DisclaimerParexel 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.