Description
DESCRIPTION:Performs a variety of qualitative and quantitative analytical assays to support raw material, in-process, intermediate and final product testing according to standard operating procedures and regulatory requirements; Performs laboratory operations necessary to support testing, such as reagent preparation/qualification, equipment and assay troubleshooting; Analyzes results and notifies Manager immediately of any out of specification or out of trend results; Candidate makes decisions regarding equipment troubleshooting along with senior analysts or manager input.
MOST CRITICAL SKILLS NEEDED:
Technical experience and practical application of relevant analytical techniques such as High Performance Liquid Chromatography (HPLC) and UV/Vis Spectrophotometery is required; Experience with ELISAs is a plus; Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; Applicant should also have strong computer skills; a strong background using a LIMS system is desirable;
*Just to reiterate, it is very important that the candidates have cGMP experience working in a Quality Control Analytical lab*
SKILLS
FDA Regulations, Quality Assurance, Quality Control, Analytical Equipment, Analytical Techniques
Synectics is an Equal Opportunity Employer.