Quality Control Chemist

Summary

The Chemist performs testing of samples in the product fulfillment process according to FDA and other applicable regulatory standards; participates in investigations related to QC processes or data; troubleshoot methods and processes.  Perform day-to day testing of all Analytical Chemistry and Microbiological Testing of Raw Materials, I-Process, Bulk and Finished Products samples.  Maintains and calibrate all Laboratory Instruments and troubleshoots testing equipment.  Preform day-to-day Lab activities.  Performs project work, develops and validated all Laboratory methods. 

Primary Responsibilities

• Follow GMP, QC methods and processes
• Trouble shoots methods and processes
• Operate laboratory equipment, process or system
• Enter and review data and other analytical equipment as appropriate
• Follow product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products
• Send an approved laboratory releases to customers
• Monitor and track instrument calibrations and preventative maintenance
• Record all QC data in the Lab note books and Lab computer system
• Report any OOS related to QC to Lead Chemist and Quality Director, such as sampling, deviations potentially affecting QC results, investigational sampling and testing
• Develops and assist for new Lab methods validation
• Perform and complete all finished product testing program
• Perform and complete all raw materials testing program

Requirements and Skills

• Bachelor Degree in a Science subject (Chemistry, or closely related subjects)
• Minimum of 3 years of laboratory experience
• Working knowledge of Microsoft office and general computer concepts
• Ability to follow GMP and SOP guidelines
• Internal and External Contact/Customers
• Good written and verbal communication skills, and problem-solving skills
• Good organizational skills with a strong attention to detail
• Ability to multi task and prioritize responsibilities
• Ability to work both independently and in a team environment
• Ability to work under pressure of deadlines.

Physical Requirements

• Ability to sit for extended hours
• Ability to view a computer screen and type for extended hours
• Other physical requirements include occasional squatting, bending, and twisting

Other Requirements

• Ability to adjust work schedule as business needs require