Lab Technician

Overview

Hours:
Training will be 7am - 3:30pm. Afterwards 9am-5pm

Preferred

Skills:

SAP, Aseptic techniques, and product experience

Temp to hire potential

Under direct supervision, the Production Lab Tech II performs various technical-level duties in the areas of manufacturing, filling, labeling, packing, shipping, and other duties as assigned in a laboratory/manufacturing environment adhering to standard operating procedures involving basic laboratory techniques, calculations, materials measurements, operation of laboratory equipment and record keeping as necessary. Daily tasks may include planning, troubleshooting SAP, helping with Dev/CAPA investigations, routine laboratory maintenance, or housekeeping.

The Manufacturing team supports production of antibody products for use in in vitro diagnostic (IVD) immunohistochemistry (IHC). All Production Lab Tech II are expected to effectively perform the job functions defined in the Essential Functions and possess the skills and abilities in the Knowledge, Skills, & Abilities sections below. Level II Production Lab Tech are expected to be highly proficient in at least two of the work areas outlined in the Work Areas and Specific Tasks listed below and are expected to develop additional skills beyond the basic skills and abilities through cross-training in some or all tasks in at least one other work area.

Level II Production Lab Tech performing Label and Documentation duties will perform all tasks in that area and will be proficient with Quality Systems or another Production - specific skill.

• Perform area clearance tasks, maintain separation of product
• Perform standard and new operating procedures
• Collect and record data on documents and batch records where required
• Utilize computer hardware and software for data entry and record keeping where required
• Ensure compliance with all Quality and Regulatory specifications
• Support process improvement through identification and reporting of areas needing improvement and assisting in improvement Utilize Quality Management Systems (OMS) and other applicable databases
• Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE):
  Safety glasses, hearing protection, protective clothing, use of automated devices and equipment designed to reduce repetitive stress, etc.
• Demonstrate attention to detail and complete work according to daily schedule
• Apply product labels based on established production plan
• Fill and package product based on established production plan
• Fill and package product using standardized techniques and practices
• Stock inventory as necessary
• Support 6S programs to maintain Lean work environment
• Work occasional overtime and weekends as needed to meet production requirements
• Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
• Report all deviations from established procedural documents to the appropriate supervisor/managers
• Additional duties as defined by management and business needs
• Participate in production failure investigations
• Attend and participate in scheduled meetings
• Compose emails to groups according to good business writing standards
• Effectively present DMS Board to management and coworkers
• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
• Other duties as assigned or required to support the business
• Planning/organizing:
  Manage time and priorities, work to meet deadlines, effectively multitask with various interruptions
• Judgment:
  Make timely decisions, exhibit sound and accurate judgment
• Additional note:
  Work Areas and Specific Tasks will further delineate responsibilities

• Safely and correctly operate standard production and fill equipment and execute filling operations
• Perform procedures involving calculations and material measurements; collect and record data on batch records
• Correctly and safely use Laminar Flow Workstations
• Safely and correctly use automated equipment such as repeater pipette, liquid pump dispenser, auto-cappers and future production automation
• Conduct support functions such as stocking and distributing supplies
• Fill various containers with products of various materials and sizes
• Use basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, and filters
• Properly handle and dispose of biologically hazardous materials and chemically hazardous materials

• Use automated equipment such as auto-labelers and future production automated equipment
• Conduct support functions such as stocking and distributing supplies
• Apply labels to product, assemble kits, and package products
• Ensure quality is maintained by verifying information is correct and work is performed per established procedural documents
• Report any inconsistencies or non-conformances discovered during procedures
• Ensure verification and final product quality Systems/…