Description GENERAL FUNCTIONS
A Laboratory Technician is responsible for preparing and performing the microbiological testing required for Internal (BD Canaan) and External (BDX) Lab Customers per established Work Instructions and Standards. A Technician must exercise accuracy in performing test procedures and must keep accurate records.
• Responsible for Sterility Testing, including SDAs, Sterility tests, and BI tests while maintaining a sterile field
• Responsible for non-sterile product Bioburden testing while maintaining a sterile field
• Responsible for LAL testing
• Cleaning and disinfection of the microlab spaces
• Environmental monitoring of the manufacturing floor and the Controlled Access Room
• Preparing media for all associated testing, and the associated quality checks, as well as sterilization of testing utensils
• OOS investigation of testing failures
• Calibration and validation of the micolab equipment
• Cleaning and decontamination glassware used in microbiological equipment
• Trend microlab testing data
• Lab Tech works with Internal and External Customers to ensure customer satisfaction, adherence to Standards and adherence to schedules
• Education in laboratory procedures and techniques or equivalent work experience is required. Strong verbal, communication and interpersonal skills are required. Aseptic skills and accuracy required in performing tests.
• Update lab policies and procedures
• Preparing product test samples as well as preparing EPCDs
• Read Preefil Validation testing
• GMP training and auditing
• Participate in audits from ISO, customers
• Other duties as assigned
•Participate fully to achieve the department’s safety goals.
•Maintain a clean and safe work environment.
•Take responsibility for own safety.
•Hold self accountable to follow all safety policies & procedures
•Debrief accidents & implement solutions to eliminate root cause.
•Hold team members to safety standards/regulations & policies.
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Required Knowledge, Experience, Skills & Abilities
Level of Education/Knowledge needed:
•High School diploma or GED or 3 years of experience in a related field or a 2-year degree in Biological Sciences
•Familiar with SAP
•Solid understanding of product specifications and the ability interpret drawings and specifications.
•Thorough understanding of quality procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product is desirable.
•2-year degree in Biological Sciences or equivalent preferred
•Knowledgeable of ISO & FDA regulations and BD Quality policies
Level of Experience needed:
•Good working knowledge of product and manufacturing processes
Level of Skills Needed:
•Proficient at reading and writing English
•Strong communication skills (oral and written) with the ability to communicate clearly with all levels of personnel including customers and auditors.
•Ability to read, write and follow Work Instructions
•Computer skills (Excel, Minitab, Word and SAP)
•Process control tools, methods and inspection equipment/tools
•Strong sense of urgency
•Strong problem solving skills / root cause analysis
•Process oriented (production, quality, etc.)
•Strong interpersonal skills
•Ability to provide feedback and assist business lead in holding people accountable
•Track record of professional behavior
•Desire for continuous improvement
•Work in a team environment
•Work with others (interpersonal skills)
•Give and receive feedback
•Solve problems and make informed decisions
•Plan and organize job tasks
•Set priorities and timelines
•Break down tasks into their parts
•Take initiative (see what needs to be done and then do it)
•Work OT without prior notice
•Move media and supplies throughout the lab
•Work with hot liquids
•Work in aseptic attire for long periods of time