Green Key Resources
Job Description Summary: The position is responsible for supporting microbiological testing, sterilization, and environmental monitoring activities. This role will focus on executing revalidation protocols, compiling reports, investigating out of tolerance conditions, and performance of microbiological testing. This position will also be required to provide support in the following activities: participation in risk mitigation activities, corrective and preventative actions, and internal audit activities with a focus on product sterilization and microbiological testing. Essential Responsibilities: \u2022 Execution of sterilization requalification protocols \u2022 Coordinate and perform test activities necessary to execute sterilization revalidations \u2022 Collect, organize, and summarize data for validation activities into reports \u2022 Organize data collected to support ongoing process control programs including but not limited to product bioburden, environmental monitoring, bacterial endotoxin \u2022 Manage investigations for out of tolerance microbial or environmental results \u2022 Assist with laboratory equipment qualification \u2022 Perform bacterial endotoxin testing and assess results Qualifications 1-2 years of related experience preferable. Stronger emphasis in laboratory background. looking direct experience with sterilization potential to be contract to hire Basic Qualifications: \u2022 Minimum BS degree in biological sciences or engineering. \u2022 Minimum 2 years combined experience in a medical device quality or laboratory environment with a focus on sterilization or microbiological testing Preferred Qualifications: \u2022 Strongly Preferred: 1 or more year microbiological laboratory experience with emphasis in bacterial endotoxin and microbial recovery testing AND\/OR \u2022 Strongly Preferred: 1 or more years combined experience with ISO-11135, Ethylene Oxide Sterilization \u2022 Bachelors of Science Degree in Microbiology or an equivalent degree in Biological Science\/related field with an emphasis in microbiology \u2022 Demonstrates knowledge of product sterilization \u2022 Demonstrates knowledge of principles of sterilization validation and associated manufacturing controls and associated methodologies \u2022 Experience with ISO-9001 Quality Systems including GMP, FDA, and ISO-13485 compliance \u2022 Experience as a quality professional in a manufacturing facility and\/or laboratory setting \u2022 Medical device manufacturing experience \u2022 Solid writing\/documentation skills highly desirable \u2022 Experience working in a collaborative environment with the ability to coordinate projects effectively \u2022 Handles routine tasks timely and accurately
Green Key Resources
Website : http://www.greenkeyllc.com/
The Green Key executive recruitment team is uniquely suited to job placement in your industry because we've actually worked in it. We know what the demands are, where the jobs are, and we have exclusive relationships with some of the most sought-after employers around. With this unique industry insight as its foundation, Green Key has committed itself to honesty, integrity, and to forming the strong, lasting relationships that have become our hallmark. Founded by a small, dedicated team of finance professionals, Green Key Resources quickly added both offices and divisions, and now proudly opens doors for candidates across ten verticals. Our expertise has expanded, but we'll never outgrow the kind of personal care and dedication a small firm can offer. We built our business around developing and maintaining long-term relationships that serve both candidates and clients, and we bring that enterprising spirit to every single placement.