Scientist 2 Microbiologist Analytical Sciences Microbiology 4324

Description

We are looking to fill a Scientist 2 Microbiologist Analytical Sciences Microbiologyposition working as a full-time employee of ExecuPharm / Parexel FSP on long-term assignment onsite at one of our clients located in Rahway NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. If interested, please send a word copy of your resume to jorcutt@execupharm.com. This position does not offer any sponsorship.

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.

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!