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.
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