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

• Maintain and enforce company-wide compliance with GMP and 21 CFR Part 820, ensuring real-time adherence across all departments, and coordinate internal and external GMP certification audits.
• Adhere to all GMP/GLP requirements
• Properly document results and assist in the development and improvement of laboratory SOPs and the maintenance of the quality assurance system
• Supervise and review analytical work, research projects, and production formulations and products
• Contribute to the development and successful launch of our new products
• 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
• Update and maintain all laboratory databases with new results for record keeping and report generation
• Injection molding processing, training, and support

EDUCATION

REQUIRED:

• Bachelor’s degree in Compliance, Quality Control, 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 Quality Controls and analytical chemistry
• Familiar with general lab equipment
• Excellent oral and written communication skills
• Proficient in spoken and written English
• Microsoft Office, Excel

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, glassware, include areas that are not well lit, the floor may be uneven or cracked, and the facility may be subject to variations in temperature.