Overview
Skills
Job Details
Research Associate II (microbiologist)
Onsite/Hybrid in Round Lake
Work Schedule: 8-hour workdays (between 7-5)
Length of Contract: 18M
Possible Contract to Hire Role? Not at this time
Interview process: (Teams/Onsite, Length, Rounds, Team involved) Teams, one round, two team members involved, 30-45 minutes
Top 3-5 Must Have Non-negotiable Skills Required
1. Basic technical understanding of sterilization (Moist Heat, Aseptic, Irradiation)
2. Basic technical understanding of microbiological method validations (sterility, bioburden and bacterial endotoxin) (specific for the Research Associate II)
3. Ability to write, execute and review validation and qualification protocols and reports.
4. Ability to Evaluate and interpret technical data and test results
Is a bachelor's degree Required? Yes
How many years of recent experience does this person need to have? 2-4 years preferred
Nice to Have Skills
1. Understanding of aseptic technique (RAII)
2. Ability to conduct experiments with minimal assistance
3. Knowledge and understanding of GxP and related regulations and guidance
Anything else you would like to add:
Both of these roles would be geared towards a Sterility Assurance support role. Ideally one will focused on Engineering and one focused on Microbiology.
Research Associate II (Microbiologist)
Effectively contribute solid technical knowledge to a variety of projects within the sterility assurance discipline with minimal assistance.
Display basic technical understanding of related sterility assurance disciplines, specifically sterilization modalities and/or microbiological test method validation.
Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines.
Maintain knowledge of relevant Quality System Regulations and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
Recommend appropriate designs, techniques and processes for a specified sequence of tasks where needed.
In-depth knowledge and understanding of GxP and related regulations and guidance.
Provide support to the Sterility Assurance Focal Point for product development or on change controls.
Write, execute and review validation and qualification protocols and reports.
Evaluate and interpret technical data and test results.
The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
Bachelor's Degree in a scientific discipline with at least 2-4 years lab experience.