POSITION TITLE: Supervisor, Quality Control Analytical
POSITION DUTIES: Curia Global, Inc. seeks a Supervisor, Quality Control Analytical to work at their Burlington, Massachusetts facility.
Specifically, the Supervisor, Quality Control Analytical position will perform the following duties:
Ensure that the analytical chemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely;
Ensure that laboratory operations are conducted in a safe manner;
Maintain compliance with regulations at all levels as well as ensure strict adherence to standard operating procedures and cGMPs as necessary;
Review the performance of QC analytical chemistry assays, HPLC, GC, IR, TOC, Particle Size and wet chemistry assays;
Conduct investigations of OOS, Deviations and Change Control Management;
Coordinate and analyze the performance of QC method qualifications, validations, and transfers;
Review the performance of QC method development and cleaning validation studies; and
Draft Quality Control SOPs, test procedures, transfer protocols and summary reports.
(Please note that this position reports to the Senior Manager, Quality Control and the position works with a team of Quality Control Analysts and Quality Control lab technicians. This is not a managerial position)
REQUIREMENTS:
This position requires a Bachelor's Degree in Chemistry, Pharmacy or related field and five (5) years as a Chemist or Quality Control analyst in a pharmaceutical environment, which includes three (3) years of pharmaceutical experience with the following:
Utilizing Empower, Chemstation and ECM software for data analysis and reporting;
Validating analytical methods;
Assisting managers with FDA audits and Out-of-Specification (OOS) investigations; and
Conducting analysis of products and stability samples in various dosages forms using the following equipment: High-performance liquid chromatography (HPLC); Gas chromatography (GC); UV Visible Spectrophotometer; Fourier transform infrared (FTIR); and Dissolution apparatus.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.