Chemist/Quality Assurance Specialist

1 week ago


Lenexa, Kansas, United States Splintek Inc. Full time
Job Summary

Splintek Inc., a leading manufacturer of healthcare products, is seeking a highly skilled Chemist/Quality Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products with regulatory standards.

Key Responsibilities
  • Supervise and review analytical work, research projects, and production formulations and products
  • Contribute to the development and successful launch of new products
  • Adhere to all GMP/GLP requirements
  • Creatively devise test methods for new product evaluation
  • Maintain stability programs to optimize product formulas and specialized packaging configurations
  • Coordinate and review out-sourced testing with research organizations
  • Maintain calibration program for lab instruments and production scales
  • Ensure company compliance with EPA, FDA, and OSHA regulations
  • Perform Quality Control testing on raw materials, intermediate, and finished products using established analytical procedures
  • Recommend changes or adjustments to operations for the purpose of improving or correcting product blends
  • Properly document results and assist in the development and improvement of laboratory SOPs and the maintenance of the quality assurance system
  • Update and maintain all laboratory databases with new results for record keeping and report generation
  • Make safety a priority consideration with all actions taken and ensure that safe work practices are followed and adhered to
Requirements
  • Bachelor's degree in Chemistry, Polymer Chemistry, or related field
  • 3 years of laboratory and quality assurance experience
  • Familiarity with ASTM and ISO test methods
  • Good working knowledge of analytical chemistry
  • Excellent oral and written communication skills
  • Proficient in spoken and written English
  • Microsoft Office
Preferred Qualifications
  • Familiarity with injection molding processing, thermoplastic polymers, and polymer chemistry
  • Familiarity with ICH guidelines and cGMP and GLP regulations
  • Familiarity with FDA regulations for medical devices
Work Environment and Physical Demands

The ideal candidate will have a strong background in analytical chemistry and quality assurance, with excellent communication and teamwork skills. If you are a motivated and detail-oriented individual who is passionate about ensuring the quality and compliance of healthcare products, we encourage you to apply for this exciting opportunity.



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