About Us
At Assure Infusions, were dedicated to producing life-saving medical products with precision, innovation, and a commitment to quality. Join our team in a brand-new facility equipped with state-of-the-art technology, where youll play a vital role in creating products that save lives.
Position Summary
As a Quality Analyst in our lab, you will be responsible for conducting detailed analyses of incoming samples, raw materials, and finished products. Your meticulous attention to detail and adherence to Good Manufacturing Practices (GMP) and U.S. Food and Drug Administration (FDA) regulations will ensure our products meet the highest standards of safety and efficacy.
Key Responsibilities
- Perform testing on incoming samples, in-process materials, and finished products.
- Follow GMP protocols and FDA regulations to ensure accurate documentation and compliance.
- Conduct a variety of analytical tests using the United States Pharmacopeia Monograph (USP) and laboratory protocols.
- Utilize Standard Operating Procedures (SOPs) to record and analyze results accurately.
- Determine next steps based on test results, ensuring all processes align with quality standards.
- Maintain precision and care to avoid errors in critical testing processes.
Required Skills and Experience
Experience with the United States Pharmacopeia and National Formulary (USPNF) : A critical resource that sets standards for the quality, purity, and strength of medicines and their ingredients. Familiarity with these protocols ensures compliance and consistency in testing procedures.Hands-on experience with advanced analytical testing equipment, including :HPLC (High-Performance Liquid Chromatography) : A precision tool used to separate, identify, and quantify components in complex mixtures.FTIR (Fourier-Transform Infrared Spectroscopy) : A method for identifying chemical structures by analyzing how they absorb infrared light.Atomic Absorption (AA) Spectroscopy : Used to measure the concentration of metals and other elements in a sample with high accuracy.TOC (Total Organic Carbon) Analysis : A technique for detecting organic contaminants in raw materials, water, and finished products to ensure quality standards.Familiarity with Empower Software, a chromatography data system widely used in pharmaceutical testing, is a strong plus.Ability to perform detailed and accurate testing while adhering to strict regulatory standards.Educational Requirements :
Bachelors Degree in Chemistry, Chemical Engineering, or Biochemistry.Equipment Youll Work With
HPLC (High-Performance Liquid Chromatography) : A technique used to separate, identify, and quantify components in a mixture, essential for ensuring product purity and consistency.AA (Atomic Absorption Spectroscopy) : A method to analyze the concentration of elements in a sample by measuring absorbed light.TLC (Thin-Layer Chromatography) : A quick and simple technique used to monitor chemical reactions and test the purity of compounds.FTIR (Fourier-Transform Infrared Spectroscopy) : Used to obtain the infrared spectrum of absorption or emission of a substance, helping identify chemical structures.UV-Vis (Ultraviolet-Visible Spectroscopy) : A method to measure the absorbance of UV or visible light in a sample, often used to quantify the concentration of compounds.Schedule
Flexible schedules required to cover 10-12 hour shifts.Must be available for occasional weekend coverage.Opportunity for night shifts as production ramps up.Compensation & Benefits
Salary : $55,000 $65,000 (DOE)100% paid health insurance (employee)401(k) with company matchLife InsuranceWhy Join Assure Infusions?
Be part of a mission-driven organization producing life-saving products. Work with brand-new equipment in a cutting-edge facility. Join a team that values precision, innovation, and collaboration.
Ready to Make an Impact?
Apply today to become a part of a team thats saving lives and setting the standard for quality in the industry.
Salary : $55,000 - $65,000
