Job Description

- We are looking for an experienced Laboratory Quality Control Manager to ensure that our products and services meet all necessary quality requirements before realizing to the market - Essential Duties and Responsibilities - Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards. - Develop and implement systems designed to support assay development, stability, raw material and finished product testing. - Facilitate the evaluation of new testing applications and instruments. Assist in the purchasing of relevant instrumentation. - Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples. - Assure that all raw materials and finished goods are tested in accordance with all regulatory, and customer requirements, as applicable. - Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification. - Manages process optimization program that includes continual improvement programs for analyses, human capital development and management systems Overall responsible for environmental monitoring program, including ensuring weekly monitoring and reporting is conducted and generating Impact Risk Assessments and quarterly/annual reports - Overall responsible for stability programs and ensuring execution within required timelines. Continuous management, development and improvement of stability program. - Overall responsibility to manage method validations/qualifications. - Investigate deviations and write exception documents as required, utilizing problem solving tools as needed. Demonstrate familiarity with product specifications, regulations, and requirements. - Responsible for investigating and processing Deviations, Out of Specifications, and Out of Trend, QC events. - Support continuous improvement in the laboratory and identify gaps in the current QC processes and plan improvement/ implementation with the QC Manager. Employment type: Full Time