Chemical Quality Assurance Specialist
4 days ago
Splintek Inc, a leading manufacturer of healthcare products, is seeking a highly skilled Chemical Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the quality and compliance of our products.
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
- 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
- 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
The ideal candidate will have a strong background in analytical chemistry and quality assurance, with excellent communication and problem-solving 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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