QC Microbiologist

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

Scorpion Therapeutics is seeking a QC Microbiologist I to ensure contamination control in manufacturing by performing environmental and water sampling/testing per USP/EP requirements. You will support operations, perform in-house microbiological assays, and prepare lab reports.

Responsibilities include OOS investigations, autoclave operation, and coordination of sample shipping. A bachelor’s degree in microbiology or related field and 2+ years of lab experience are preferred.

Qualifications

• Working knowledge of cGMPs, USP/EP requirements for microbiology activities.
• Proficiency in viable and non-viable environmental monitoring and aseptic technique.
• Ability to work independently and as part of a team.
• Microsoft Office proficiency.

Responsibilities

• Support manufacturing operations including process validation, environmental monitoring, and utility systems sampling/testing.
• Perform environmental, water, and other utility sampling procedures.
• Perform in-house microbiological assays.
• Evaluate microbiological results including microbial identification as needed.
• Prepare timely analytical lab reports/summaries.
• Conduct environmental and utility OOS investigations as needed.
• Operate the autoclave to supply sterile testing materials.
• Ensure laboratory testing materials are readily available.
• Schedule and coordinate shipping of samples to contract laboratories.
• Troubleshoot instruments and coordinate with lab manager/equipment services; calibrate and standardize per SOPs.

Skills

cGMP knowledge

Environmental monitoring

Team collaboration

MS Office

Education

Bachelor's degree in microbiology or related field

Tools

Trackwise

MasterControl

LIMS

Job description

Who You Are

The QC Microbiologist I ensures contamination control of manufacturing facilities by performing environmental and water sampling/testing per USP and EP requirements where applicable. Ensures timely and accurate material testing while maintaining quality and compliance.

Responsibilities

• Support manufacturing operations including process validation, environmental monitoring, and utility systems sampling/testing
• Perform environmental, water, and other utility sampling procedures
• Perform in-house microbiological assays
• Evaluate microbiological results including microbial identification as needed
• Prepare timely analytical lab reports/summaries
• Conduct Environmental and utility out-of-specification (OOS) investigations as needed
• Operate the autoclave to supply sterile testing materials
• Ensure laboratory testing materials are readily available
• Schedule and coordinate shipping of samples to contract laboratories
• Troubleshoot instruments; coordinate with lab manager/equipment technical services; perform maintenance and calibration verification/standardization per SOPs

Minimum Requirements

• Working knowledge of cGMPs, USP, EP, and other regulatory requirements for microbiology activities
• Proficiency in viable/non-viable environmental monitoring (gram staining, sub-culturing, bioburden testing, gowning, aseptic technique)
• Ability to work independently and with a team
• Microsoft Office (computer application skills)

Preferred Requirements

• Bachelor's degree in microbiology, biology, biochemistry, or related discipline
• 2+ years relevant microbiology lab experience with aseptic processing
• Familiarity with Trackwise, MasterControl, and LIMS
• Pharmaceutical GMP experience

Job Location

In-person from Research Triangle Park, NC facility 100% of the time.