Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
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 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 with the trainings assigned online 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 and 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)
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