Scientist III Microbiologist - FSP
About The Position
Parexel FSP is seeking a Microbiologist to work as a full-time employee on a long-term assignment onsite at one of their clients in West Point, PA. This role involves performing microbiological product analysis, including sample analysis, data compilation, investigations, and preparing/responding to CAPA. Responsibilities also include reviewing and revising test procedures and SOPs, and performing various microbiological activities such as microbial limits testing, endotoxin testing, environmental monitoring, bioburden testing, and water sampling. The role also requires executing "Before-Use" calibrations, preparing GMP documentation, performing laboratory and equipment sanitizations, and participating in audits and training. The position is intended to be 40 hours per week.
Requirements
- Bachelor’s degree required; concentration in a scientific or applied discipline strongly preferred
- 3-5 years of experience in pharmaceutical microbiology related position required
- Solid microbiology foundation with experience in performing product testing
- Proven technical writing skills (SOPs, protocols)
Nice To Haves
- MS with 1-2 years of 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 (Corrective and Preventative Action)
- Review, revise Test Procedures / Standard Operating Procedures
- Ad Hoc work
- Rotational on-call assignments
- MICROBIOLOGICAL ACTIVITIES: Receive, verify & Log in samples
- MLT (Microbial Limits Testing)
- 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 (Electronic Laboratory Notebook)
- 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
Benefits
- full benefits
- sick time
- 401K
- paid holidays
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
