QC Microbiology Technician

About the role

The QC Microbiology Technician will work closely with QC Microbiologists and the QC Microbiology Manager to support development and readiness activities for the Quality Control Microbiology lab. The QC Microbiology Technician will perform routine sampling for items undergoing QC testing, perform routine microbiology techniques and assays to generate data needed for product support, and manage day-to-day tasks within the lab including but not limited to consumables ordering, daily instrument calibration/verification, and laboratory waste management.

Responsibilities

• Perform routine sampling for items undergoing QC testing
• Perform routine microbiology techniques and assays to generate data needed for product support
• Manage day-to-day tasks within the lab including but not limited to consumables ordering, daily instrument calibration/verification, and laboratory waste management
• Support the lab in maintaining efficient operation by supporting our Quality Mindset with skills including attention to detail, on time delivery, and commitment to Quality excellence
• Exemplify team-oriented behaviors, and willingness to act as both a facilitator and a contributor to special projects as needed
• Maintain a constant state of safety and inspection-readiness in the QC microbiology laboratory
• Collaborate internally to resolve quality non-conformance events regarding facility, in-process, finished, and released
• Performs routine environmental monitoring and collection of utilities within facility
• Performs common microbiology testing on incoming media and utility samples adhering to best practices that align to SOPs, compliance requirements, quality guidelines, and site goals
• Performs routine preventative maintenance on QC lab instrumentation as needed using written SOPs or assists vendors with access to systems/materials when vendor performs maintenance
• Performs troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)
• Provides support during laboratory investigations
• Manages Laboratory waste while adhering to Environmental, Health, & Safety standards required in a GMP lab
• Supports manufacturing process control & process improvement projects
• Diligently maintains laboratory documentation to ensure organization and regulatory compliance

Requirements

• Bachelor’s degree in science (Chemistry or Biochemistry preferred) or equivalent related experience
• Strong math and documentation skills
• Strong oral and written communication and interpersonal interaction skills
• Ability to work in a highly regulated environment

Qualifications

• Working knowledge of laboratory instrumentation and methods supporting endotoxin and bioburden analyses
• Demonstrated experience with environmental monitoring
• Experience with Continuous improvement, Six Sigma, and/or Lean principles

Benefits

INCOG BioPharma Services offers a competitive compensation package, comprehensive health and wellness benefits, and opportunities for professional growth and development. We are committed to fostering a diverse and inclusive workplace where all employees feel valued and supported.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position.

Additional info about INCOG BioPharma Services

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you.

Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. By submitting your resume and details, you are declaring that the information is correct and accurate.