Job Title: Quality Control Chemist/Analyst
Reports Directly To: Quality Control Manager
Under the direct supervision of the Quality Control Manager/Distribution and Quality Director/Manufacturing
Be responsible for the finished product testing conducted at contract labs and manufacturing sites including sampling, sending out samples analyzing results and reporting data to QC manager/director at appropriate site.
Responsible for maintaining Independent verification testing programs with 3rd party contractor.
Responsible for the in house testing conducted at manufacturing site to include Raw Material, In process and finished product testing.
Responsible for Out of Specification reporting, deviation for both Internal Lab and Contract lab testing and corrective actions as necessary.
Responsible for method development of testing protocols based on validated compendial monographs.
Responsible for maintenance of lab equipment, scheduling outside maintenance when needed, troubleshooting as required.
Keeping lab equipment in good working order, keeping labs stocked with supplies including purchasing goods needed from appropriate vendor.
Responsible for analytical testing protocols (i.e. HPLC, GC, Vitamin C titrations, wet chemistry analysis as developed, FTNIR, Atomic Absorption ICP as applicable, Water Activity etc at manufacturing site)
Responsible for keeping account of accuracy of all lab operations, including standards for raw material testing, in process testing and finished product testing.
Develop in house library of standards for raw materials
Work with Rand D and product development on testing materials to meet product specification requirement
Raw Material Specification , In process specification and finished product specification development and testing.
Write SOP’s as pertaining to Quality control laboratory operations.
Develop Raw Material Standards Library.
Report findings to Quality management to form proper CAPA documentation
Responsible for CAPA database, Deviation Database Investigation database, trending and metrics.
Report to Quality management the calendaring necessary to complete CAPA,investigations and deviations in a time effective manner.
Set up and maintain raw material specifications with purchasing department and product development finished product specification with product development and quality assurance.
Maintenance of water testing, calibration records, temperature humidity monitoring.
Back up Microlab as needed
Back up Quality control functions as needed sampling, staging, inspections
Follow and work in GMP requirement as directed.
Requirements: Must be able to lift 25 pounds, must be able to stand, bend, stretch.
Must be able to stand for extended time intervals during the work shift.
Must have good oral communication skills to be able to complete work tasks as
instructed. Must be able to work in a Good Manufacturing environment as directed.
Degree in science discipline. Three years related experience.