Kelly Scientific Resources is seeking for a Quality Control Microbiologist
Project involves the development of a new type of bacteria sensor for clinical use. Project work involves working with other scientific experts on a cross-functional team using cutting edge techniques to fabricate polymers at a nano-level and understand their interaction with common types of bacteria.
The candidate would lead in the implementation and development of design controls i.e. Design Input / Output, Design Verification and product risk management i.e.Hazard Analysis, Fault Tree, FMEAs based on risk assessment, customer needs, clinical benefit, and manufacturing input. Through careful literature searches and input from various SMEs, drafts technical requirements and refines them based upon testing and analysis. Designs and develops a wide variety of statistically valid microbiological, biocompatibility, and drug interference test methods in accordance with above requirements.
Drafts verification protocols and summarizes the results in a final verification report. Documents data, labels samples, and records observations meticulously and clearly. Troubleshoots existing test methods using six sigma approaches to establish robust and capable testing through the use of gauge studies and tool qualifications. Identifies out-of-specification conditions, Conducts Root Cause Investigations, and participates in identification of appropriate corrective actions. Functions as the Subject Matter Expert SME for microbiology, biocompatibility, and drug interference topics for the purpose of regulatory audits, investigations, and regulatory submissions. Manage the testing programs and ensures all verification and validation is performed per internal and external requirements. The candidate would also supervise and setup the onsite laboratory and in house testing program as needed.
Laboratory setup includes equipment installation and qualification, culture media qualification, lab equipment calibration and maintenance. Interface with outside testing laboratories for various microbiological, biocompatibility, and drug interference tests which may involve initial setup and periodic inspections for conformance. Clear and concise communication to remote colleagues and supervisors in the form of written reports and polished presentations. Prepare status updates to management, and recommendations based on experimental results.
Candidate Background : The ideal candidate has worked in a quality control capacity as a microbiologist with some material science / polymer familiarity. Familiarity with cell culture systems, media preparation, buffer preparation, various cell counting techniques spectroscopy, plate counting, flow cytometry is required.
Some previous experience regarding pre-sterile microbial load studies, sterility testing, bacterial endotoxin testing, on specialized substrates is preferred. Knowledge of biocompatibility of polymers is also a plus.
A minimum of a Master s degree in Biological Sciences, Biomedical Engineering, or a related field and 3-4 years of related laboratory experience is required or equivalent combination of education and experience to perform at this level .
Experience working with cGMP and GLP per an FDA regulated environment is required.Knowledge of statistical data analysis tools i.e. Minitab is required. ASQ CQE certification or Six Sigma Green Belt certification preferred. May require flexible hours for initial setup of testing. May require up to 25 travel.
Compensation will depend on experience. Highly competitive salaries and excellent benefits.
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services.
Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
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