Job Description:
We are seeking a skilled professional to join our team as a Senior Staff Microbiologist. The successful candidate will be responsible for defining local quality strategies, overseeing key processes, and coaching colleagues in the area of microbiology.
Key Responsibilities:
* Develop and implement local quality strategies to ensure safe and high-quality products.
* Oversight of micro and sterility key processes including cleaning, cleanroom, sterilization, and product testing.
* Coach, mentor, and drive awareness among colleagues on micro and sterility best practices.
* Subject matter expert on internal and external regulatory requirements, and local procedure owner.
* Interpret sampling and monitoring data, applying statistical techniques to determine control and trending.
* Review and approval of cleaning, cleanroom equipment, process qualification, validation, and monitoring reports.
* Timely communication, escalation, and resolution of product issues causing supply chain disruptions.
Required Skills and Qualifications:
The ideal candidate will possess a Bachelor's degree or Master's degree in Microbiology or equivalent. A minimum of 6 years of relevant experience is required, with at least 2 years in microbiology-related roles. Experience interacting with regulatory agencies (MDSAP, FDA, MoH, TUV) is necessary.
The candidate must have thorough knowledge and understanding of US and international medical device regulations and standards in the area of microbiology. Strong communication, project management, and influencing skills are essential, along with the ability to manage multiple tasks simultaneously.
The successful candidate will also possess strong interpersonal skills, written and oral communication skills, critical thinking skills, and problem-solving abilities. They must be proficient in Microsoft Word, Excel, and PowerPoint packages.