Job Summary
The Lab Technician I is responsible for execution and recording of results for all laboratory testing. This position will support all sterility assurance, product quality, & endpoint testing for operational support and release. In addition, the Lab Technician I will support all activities to sustain required testing and monitoring, this to include sample collection, shipping, testing submittal forms, and purchase order generation. The Lab Technician I will assist and maintain department equipment and consumables related to environmental monitoring, product testing, and sterility assurance activities.
Essential Duties and Responsibilities
- Execute and record results of all laboratory testing conducted, which includes, but not limited to, viable and non-viable air monitoring, microbial surface testing, media testing, endopoint testing and water testing.
- Execute laboratory assays as trained and directed to support product quality monitoring.
- Ability to perform basic aseptic transfer technique in microbiological assays
- Ability to operate basic lab and test equipment
- Responsible for accurate and organized maintenance of quality records according to the established procedures.
- Communicate effectively within the organization to ensure proper action is taken to resolve corrections needed.
- Coordinates and assists in equipment preventative maintenance, calibrations, and qualification activities.
- Assist with sterilization validation execution, including product sample coordination and dunnage builds.
- Maintains accurate records.
- Ability to communicate findings effectively in oral and written form with the aim of improving processes.
- Manage and order laboratory and equipment consumables
- Coordinate off-site testing studies, including sample collection, shipping, and purchase order requisition
- Draft/revise Quality/Sterility Assurance procedures with sterility assurance team support.
- Suggests and documents process changes to support projects and process improvements.
- Liaise with quality assurance, engineering and development groups for all environmental monitoring and lab testing issues.
- Willingness to work as part of a team, contributing ideas to improve processes.
- Willingness to expand knowledge base in support of team's primary functions.
- Other duties as assigned to support environmental monitoring, product cleaning, product testing, and sterilization..
Supervisory Responsibilities
No
Qualifications (Education, Certifications and/or Experience)
- High School or equivalent; associates degree or college level biology and chemistry course work preferred.
- Excellent oral and written communications skills.
- Minimum one-year experience working in a regulated environment. (Waived if attained an Associate degree or higher)
- Ability to work independently with little direction.
- Ability to follow and meet schedules and timelines.
- Ability to work varied schedules and overtime hours as necessary.
- Understand and follows QSR, ISO, and departmental procedures.
- Experience in Microsoft Office (word, excel, etc.).
Work Environment
- Exposure to a medically controlled environment, subject to interruptions, subject to changing conditions.
- Protective Personal Equipment required as indicated by area procedure.
- Physical Requirements: prolonged standing, sitting, and/or walking. This position may also require: hands to finger motion, handling, reaching with hands and arms, balance, stooping, kneeling, or crouching.
- Medium Work: Will occasionally need to lift and/or move up to 30 pounds (see assistance for greater amounts)
- Visual Demands: Near acuity; ability to see at 20 inches or more, distance vision, peripheral vision, depth perception, and the ability to adjust focus.