Job title: Microbiologist
Location: Boulder, CO
Duration: 12+ months (Possibility of extension)
JOB ROLE
- The Microbiologist I position coordinates microbiological testing on Raw Material, Finished Products and QA samples - such as Sterility Testing, Bacterial Endotoxin testing, Particulate Matter testing, Bioburden test, Antibiotic assays, Microbial Limits test, Preservative Effectiveness test, Container Closure Integrity test and Bacterial Retention tests.
- Support validation functions. Performs enumeration of Biological Indicators.
- Maintains user logs and BI history data.
- Helps to maintain environmental monitoring results and and identifies environmental isolates and challenge areas.
- Performs evaluation of resistance microorganisms or spikes in bioburden.
- The position will support the performance and documentation for recertification of clean rooms and plant systems.
- Follows the company Safety, Health, and Environmental policies and procedures.
ESSENTIAL FUNCTIONS:
- Responsible for specific scientific testing and provides back-up on other key test areas.
- Performs testing to meet USP, ISO, EN, and ASTM standards for product release and QC testing.
- Implement test procedures for updates and changes.
- Accountable for specific test data and can train on specific lab tests.
- Perform laboratory duties to support department objectives.
- Supports the Quality Assurance Program for external audits (FDA, ISO 9000)
- Responsible for compliance with EHS goals for this position
- Responsible for compliance with Quality goals for this position
- Responsible for compliance the trainings assigned on line or interactive.
- Responsible to know the impact about the inadequate performance of his\her work in the products defects.
- When applicable sterilization batch review and release
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Other duties as assigned with or without accommodation.
- All employees are expected to pay attention to and work in support of a safe and healthy work environment.
- This includes following the established rules, policies and practices of environmental, health and safety with specific attention to the Client Cardinal Rules.
- Performs other duties and responsibilities, as required.
MINIMUM REQUIREMENTS:
Education required/ Preferred: • BS/AS in Microbiology or equivalent scientific field
Experience: • 1-3 years of experience in a Microbiology Lab with at least 1 year in a Medical Device environment
Preferred Skills/Qualifications:
Skills/Competencies:
- Customer Focus
- Ethics & Values
- Managing an Measuring Work
- Action Oriented
- Problem Solving
- Decision Quality
- Informing
Other Skills:
- General knowledge of cGMP's/ISO 13485: 2003
- Validations
- Computer Software Knowledge (Word, Excel)