Position : Chemist (M+0)
Develop and improve analytical methods; Prepare Test Solutions, compounds, and reagents to conduct test on raw material, finished products, in-process sample, and stability samples; Perform analytical method validations, cleaning validations, and process validations; Coordinate and manage samples for chemical testing, and stability testing, as well as lab documentation for QC operations; Confer with lab managers to conduct analyses of research projects, interpret test results, or develop nonstandard tests. Develop and enforce Standard Operating Procedures in the QC lab as per the regulatory requirements; Write Operational Standard Operating Procedures for the lab equipment; Prepare required investigation reports, deviations, out of specifications and analyze out of trends; Address customer quality complaints with root cause analysis.
Master of Science Degree in Chemistry, Pharmacy or Regulatory Affairs is required.
Must have knowledge of Human Physiology, Forensic Pharmacy, Pharmacognosy, Phytochemistry & Applied Biochemistry.
Position : QC Chemist
Develop and Implement policies and procedures in compliance with local, state, federal, Occupational Safety and Health Administration (OSHA) and FDA rules and regulations; Control the quarantine and release of Raw Materials, and finished product in accordance with criteria, included in the Certificate of Analysis; Develop and enforce standard operating procedures to comply with all regulatory and CGMP requirements (21 CFR 110-111); Coordinate, and manage samples, chemical testing, and stability testing, as well as lab documentation for QC lab; Introduce, coordinate, and implement new test methods, products and equipment into the QC lab; Prepare required investigation reports, deviations, Out of Specifications (OOS), and Out of Trend (OOT) reports; Coordinate and manage customer quality complaints and supports any/ all federal and state inspections; Prepare and review process verification protocols and technical documents.
Master of Science Degree in Chemistry, or Pharmacy plus 12 months of experience in Related Occupation is required.
Please apply with two copies of resume.
468 Mill Road
Coram, NY 11727