Job Description Summary

Performs testing that assures the sterility of BD product, in addition performs environmental monitoring of manufacturing areas to ensure that product integrity. Familiarity with Microbiology techniques, equipment and good laboratory practices, including a working in clean room atmosphere is preferred. Duties will include collection test samples, media preparation, verification/calibration of equipment, upkeep of various laboratory databases, routine housekeeping, and providing support to special projects. Performs consistent and accurate analysis and documentation in accordance with procedures. Ability to perform successfully within a detail-orientated, results driven atmosphere is required.

Job Description

• Completes work assignments efficiently as outlined by procedures independently or within a team.
• Performs media preparation and quality control of media for laboratory testing.
• Washes and maintains labware and glassware. Ensures cleanliness confirms integrity before use.
• Documents the verification, monitoring and/or calibration of all applicable laboratory equipment as required by regulatory and quality control functions. Equipment includes: Incubators, Refrigerators, Freezers, Dishwasher, Peristaltic Pumps, Laminar Hoods, UV Lamps, Heat blocks, Depyrogenation Oven, Shakers, pH meters, and Water baths).
• Operation and general maintenance of all laboratory equipment.
• Performs tasks with extra attention to aseptic technique, both in the general laboratory area and the Clean Room environment. 
• Performs general microbiological techniques such as plates counts, plating, staining, streaking and identification of isolates.
• Performs routine sample collection and microbial analysis of raw materials, product components, water-based solutions, and plant water to monitor aspects that can contribute to product bioburden.
• Documents results of pre-sterile finished product bioburden, sterilization dose audits, bacteriostatic/fungistatic analysis, sterility tests, biological indicator testing, bacterial endotoxin test, environmental monitoring for particle and viable levels, and additional tests conducted in the Microbiology Laboratory, using calculations if needed. 
• Responsible for planning and ensuring adequate supplies are available to support testing to meet QSR and regulatory test frequencies.  This would include ordering supplies.
• Identifies and reports “out of spec” conditions immediately to Microbiologist and participates in additional testing, completing investigations, and implementing corrective actions as directed.
• Prepares and issues reports relevant to data acquisitions.
• Records test results using spreadsheets and databases for results analysis of test data.
• Logs incoming laboratory samples into receiving/testing database, in addition maintains databases and spreadsheets.
• Performs routine housekeeping duties to include: keeping a clean and organized office/lab space, disinfection of work surfaces before and after use, and routine removal of samples at appointed time periods.
• Participates in test scheduling as required.
• Participates in maintenance of the plant finished product retention program.

Requirements:

• High School Diploma / GED
• Associates of Science
• 3-6 months of clean room work experience
• 3-6 months of aseptic experience

Preferred Requirements:

• Bachelor's of Science - Natural Science / Biology / Microbiology
• ISO 13485 experience
• 1-5 years of experience working in a clean room environment
• environmental testing (air / water) experience

Primary Work Location

USA SC - Sumter

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)