About The Position

The Biomaterials Associate is responsible for supporting production operations in a regulated environment while ensuring compliance with standard operating procedures, quality requirements, and safety standards. This role performs visual and dimensional inspections, maintains accurate production documentation, assists with various manufacturing processes, and helps ensure products meet quality specifications. The ideal candidate is detail-oriented, quality-focused, and capable of working effectively in a fast-paced manufacturing environment.

Requirements

  • Maintains the work area and equipment in a clean orderly condition and follows safety regulations.
  • Working knowledge and understanding of all applicable Standard Operating Procedures and supporting documentation.
  • Ability to use commonsense to find resolution when faced with challenges to carry out instructions.
  • Basic algebra and basic statistical analysis of data sets including standard deviation and related to quantities and chemical concentrations calculations.
  • Ability to read and interpret documents such as safety rules, operating/maintenance instructions, and procedure manuals.
  • Regularly required to walk, sit, stand, bend and twist.
  • Requires some lifting and carrying of equipment of 25 pounds or mildly greater.
  • Vision abilities required for this job include close vision, distance vision, peripheral vision and depth perception and the ability to adjust focus.
  • Repetitive use of hands, controlled grasping, and fine manipulation.

Responsibilities

  • Comprehensive understanding of all applicable MSOP’s, QCSOP’s, GMP (Good Manufacturing Practices), and line clearance requirements.
  • Maintain proper documentation per GDP (Good Documentation Practices) by filling out work orders correctly and accurately recording accepted and rejected quantities.
  • Keep workspace clean, organized and follow safety requirements.
  • Perform visual inspection of material to identify defects.
  • Perform automated and manual dimensional inspections of material to identify defects.
  • Accurately record rejects on device history record (DHR).
  • Perform breakout process by removing rods from glass tubes.
  • Perform visual inspection of the rods.
  • Assist polymerization process with monomer filling and capping tubes.
  • Assist with unloading and cleaning polymerized rods.
  • Assist with feeding rods for rod grinding operations.
  • Assist with feeding rods for rod lathing operations.
  • Measure dimensions of blanks for daily sawing operations.
  • Assist with blank washing and sorting operations to ensure blanks are washed, dried, and sorted.
  • Report process non-conformances to leads, supervisors, or quality control.
  • Ensure that all finished products meet quality standards and specifications.
  • Listen and communicate effectively with technicians and leaders about any production, quality, or safety issues.
  • Other duties as assigned.

Benefits

  • Medical
  • Vision
  • Dental
  • 401k Matching
  • Employee Assistance Programs
  • Vacation and sick pay
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