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Senior Reprocessing Laboratory Specialist - Charlton Massachusetts
Company: Disability Solutions Location: Charlton, Massachusetts
Posted On: 05/04/2024
I. Job Purpose and Core Tasks The Senior Reprocessing Laboratory Specialist is responsible under minimal supervision for providing support to the Global Reprocessing, Sterilization, and Biocompatibility department and other internal KARL STORZ departments through the planning and execution of laboratory tasks and test methods including product processing through cleaning, disinfection, and/or sterilization cycles and cleaning validations. The position also acts as a corresponding consulting partner with the main interacting departments regarding routine reprocessing cycles and cleaningvalidations.Core Tasks: - Performs under minimal supervision reprocessing methods (cleaning, disinfection, and sterilization) on products in order to simulate use of instruments prior to testing.
- Operates sterilization equipment and standard laboratory equipment.
- Performs routine laboratory activities including preventative maintenance and calibration of equipment, material inventory and ordering, and general laboratory housekeeping.
- Under minimal supervision follows test protocols and laboratory standard operating procedures and processes.
- Accurately completes required documentation according to good documentation practices (GDP) for all laboratory functions.
- Works both independently and as part of small project teams.
- Writes and reviews standard operating procedures and test protocols.
- Plans and executes reprocessing validations for reusable devices.
- Analyzes, interprets, and presents laboratory results.
- Participates in the development and improvement of standard operating procedures and processes.
- Delivers training to laboratory personnel on standard operating procedures and work instructions, laboratory practices, equipment use, and qualification on test methods. II. Minimum Knowledge, Education and Skill Requirements
- Bachelor's degree in chemistry, microbiology, biology, or related scientific field OrRelevant certification (e.g. sterile processing) and 5 years minimum of direct laboratory experience with reprocessing of reusable medical devices
- 5-10 years of experience in a regulated (GMP or GLP) laboratory environment.
- Experience with reprocessing of reusable medical devices required. Familiar with sterilization (steam, vapor hydrogen peroxide, and liquid chemical sterilization), high level disinfection (manual and automated processes), and cleaning (manual and automated processes).
- Familiar with reprocessing-related standards and guidance (AAMI TIR12, AAMI TIR30, AAMI TIR34, ANSI/AAMI ST58, ANSI/AAMI ST79, AANSI/AAMI ST91, ISO 15883, etc.).
- Experience with analytical laboratory test methods and equipment - protein, hemoglobin and carbohydrate detection preferred.
- Experience with test data analysis using Microsoft excel - standard curve and concentration calculations an advantage.
- Experience with protocol development, execution, and technical report writing an advantage.
- Proficient in Microsoft Office programs (e.g. Word, Excel, Outlook). III. Essential Function
- Must be able to maintain productive working relationships and treat fellow employees with respect.
- Has contact with: Internal departments including Product Development, Product Management, Engineering, Quality, and Regulatory Affairs Physical requirement/Demands:
- Must be able to work in a professional laboratory setting.
- Must be able to lift --- 25 lbs.
- Some domestic and international travel may be required. Mental requirements/Emotional Demands:
- Must be well-organized, capable of multi-tasking and managing multiple projects and/or tasks at once. Interpersonal and communication skills:
- Must be able to maintain productive working relationships with co-workers.
- Must treat fellow employees with respect.
- Effective verbal and written communication skills; must be able to express ideas clearly (both written and verbally) to a wide variety of personnel at various levels, as well as personnel at other facilities for which English may not be a first language. IV. Core Requirements:Safety:
- Must be able to maintain compliance with Company policies on occupation health and safety.
- Must be able to handle various chemicals according to EH&S policies and procedures.
- Must be able to work while wearing appropriate PPE (e.g. safety glasses, gloves, etc.). Quality:
- Must be able to maintain compliance with Company policies, SOP's, and relevant work regulations. Travel:
- Domestic and/or international travel may be required Your Benefits
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