harbaheadercoverblack.png

Quality Control Microbiologist

Indianapolis $28.00 - $32.00 p/h Contract

Responsibilities:

  • Maintain operational compliance with U.S. and international regulatory agencies and guidelines (e.g., FDA, ISO, USP, cGMP, etc.).
  • Conduct Sterility, Endotoxin, Particulates, and Bioburden testing on drug products, intermediates, and raw materials using aseptic techniques, following USP guidelines and internal SOPs.
  • Execute Growth Promotion testing in line with USP methods for various microbiological media.
  • Prepare and analyze Biological Indicators to support Validation and Qualification activities.
  • Quantify microbial growth, subculture pure isolates, and document findings accurately.
  • Enter and review data in Laboratory Management Systems (LIMS).
  • Perform general laboratory housekeeping and routine maintenance of laboratory premises and equipment.
  • Conduct in vivo biological performance testing to support product efficacy and quality according to USP and internal standard test methods.
  • Collaborate with team members to ensure the timely and consistent completion of testing and other department objectives.
  • Support laboratory investigations, root cause analyses, and assist in the implementation of corrective and preventative actions (CAPA).
  • Adhere to safety protocols and maintain compliance with quality and site-specific operational guidelines.
  • Participate in inventory management and ensure adequate stock of laboratory supplies.
  • Assist with monthly equipment safety inspections.
  • Help train less experienced technicians as needed.


Qualifications:

  • Bachelor of Science in Microbiology, Biology, or relevant field of study.
  • 3+ years of relevant experience in a laboratory or regulated environment.
  • Experience working in a cGMP-regulated production or quality environment.
  • Strong interpersonal, analytical, problem-solving, and decision-making skills.
  • Excellent written and verbal communication skills.
  • High attention to detail and strong organizational skills.
  • Proficiency with computers and data entry systems.
  • Flexibility, adaptability, and a commitment to teamwork.
  • High level of energy with regular, consistent attendance.
Share this job:

Apply now

Similar Jobs

Inspection and Packaging Supervisor

Indianapolis $80,000 - $105,000 Permanent

Responsibilities: Provide technical support and leadership in the implementation of visual inspection program. Train inspection operators and...

Electrical Engineer

Bloomington $70,000 - $100,000 Contract

Responsibilities: Support and lead projects involving the design, installation, and commissioning of electrical systems for manufacturing equipm...

Senior TSMS Engineer

Indianapolis $110,000 - $120,000 Contract

Job Description: Provide expert technical support to manufacturing operations including sterile drug product formulation, filling, and packaging...

Supplier Quality Engineer

Indianapolis $110,000 - $120,000 Permanent

Job Description: Lead the evaluation and qualification of suppliers for raw materials, components, and services used in drug product manufacturi...

Maintenance Technician

Boston $40 - $45/HR Contract

Job Responsibilities: Maintain and inspect all equipment throughout the facility including, but not limited to HVAC, Water-For-Injection (WFI) s...