Must-haves

Bachelor's degree in a scientific discipline (Microbiology or Biological Sciences preferred

In depth knowledge of GMP standards and regulations

2 years of experience in pharmaceutical industry in a microbiology related position

Experience with routine drug product testing and environmental monitoring

Experience with Sterility testing and aseptic technique

Day-to-Day

Insight Global is seeking a microbiologist to support a pharmaceutical client in Rahway, NJ. This microbiologist plays a crucial role in ensuring the microbiological integrity of pharmaceutical products and manufacturing areas. This professional conducts thorough environmental monitoring to uphold regulatory standards in GMP regulated spaces and conducts routine testing of drug products to detect and prevent microbial contamination. This position is on-site 5 days a week and is a first shift opportunity.

Higher level overview:

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

• 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 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