Microbiologist
Isotopia USA
- Westfield, IN
- Permanent
- Full-time
- Performing microbiological testing of raw materials, in-process materials, and finished product for batch approval and release.
- Development and management of an environmental monitoring program.
- Supporting the development and execution of a microbiological trending program and preparation of periodic reports for the facility.
- Supporting and executing qualifications and validations for microbiological testing equipment and site sterility assurance programs.
- Leading investigations for OOS (out-of-specification) environmental monitoring recoveries and sterility testing and for other issues related to aseptic processing deviations.
- Providing input and support for resolution of facility issues and CAPA (corrective actions/preventive actions).
- Preparing materials and training for aseptic principles and contamination control.
- Performing routine inspections of laboratory notebooks and of the laboratory environment in accordance with written inspection procedures.
- Maintaining inventory of materials required for microbiological testing.
- Assisting with qualification, calibration, and maintenance of EM sampling equipment (viable and non-viable sampling equipment).
- Coordinating sampling plans and shipment of samples to third party labs for any necessary third-party testing.
- Development and implementation of a contamination control plan.
- Performing any other tasks related to analytical testing as necessary.
- Bachelor’s degree in biology, microbiology, or related life science is required.
- Previous experience with USP microbiological test methods such as sterility and bioburden is preferred.
- Previous experience in pharmaceutical / radiopharmaceutical quality control is preferred.
- Strong understanding of cGMP requirements and radiation safety practices is preferred.
- Detail-oriented mindset with excellent organizational and record-keeping skills.
- Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
- Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
- Flexibility to work in shifts and handle time-sensitive processes.
- Strong commitment to safety, ethical conduct, and compliance with regulations.
- Physical ability to stand for extended periods, lift moderately heavy objects up to 50 pounds, and to handle frequent stooping and crouching, and wear appropriate PPE.