Description

Splintek is a Lenexa based, made in the USA manufacturing company in the business of providing high-quality healthcare products to Retailers, Professionals and direct to consumers since 1996. Innovation, team-based, high energy, casual business environment. Splintek’s mission is to enhance the quality of life globally by innovating healthcare products for better sleep, more comfort, and overall health. Please visit our website at www.sleepright.com

PRIMARY OBJECTIVE OF POSITION

Perform standardized qualitative and quantitative tests to determine the physical or chemical properties of various materials to ensure compliance with company and government standards, assure regulatory compliance, and research and development of new products.

DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS

Supervise and review analytical work, research projects, and production formulations and products
Contribute to the development and successful launch of our 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
Injection molding processing, training, and support

Requirements

EDUCATION

REQUIRED:

Bachelor’s degree in Chemistry, Polymer Chemistry, or related field

EXPERIENCE AND SKILL

REQUIRED:

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:

Familiar with injection molding processing, thermoplastic polymers, and polymer chemistry
Familiarity with thermoplastic molding and part production
Familiarity with ICH guidelines and cGMP and GLP regulations
Familiarity with FDA regulations for medical devices.
Instrumental analysis, including GC and GC-MS (HS-GC-MS preferred), DSC, FTIR, optical profilometry and optical microscopy

**We are NOT interested in working with recruiters or employment agencies at this time. Please do not email about potential candidates.

WORK ENVIRONMENT AND PHYSICAL DEMANDS

Vision: Use vision to read, write, type, operate office, electronic, and manufacturing equipment, and make fine adjustments.

Speaking/Hearing: Give and receive information through speaking and hearing.

Motor Coordination: Requires hands to operate equipment.

Lift/Carry: Regularly lift, push, and move up to 50lbs.

Environment: Office and warehouse environments may be dust, contain sharp edges, include areas that are not well lit, the floor may be uneven or cracked, and the facility may be subject to variations in temperature.