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Job #02712

About our client Our client is a rapidly growing custom and specialty chemical manufacturer serving the pharmaceutical and biotechnology industry. The company has an experienced management team, a strong track record with the FDA and an empowering corporate culture that is focused on the long- term professional development of its employees. Position Location Quality Assurance Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform quality control function in full compliance with current Good Manufacturing Practices 2) Schedule work flow and supervise QC Analyst and method development chemists 3) Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product and stability samples 4) Review and approve analytical method, development reports, validation protocols and validation reports 5) Release raw materials for use in manufacturing 6) Assist in writing and updating quality control test procedures and documentation as per department regulations and company objectives 7) Conduct lab Out of Specification (OOS) investigations 8) Handle transfer of validated methods from method development to quality 9) Improve existing standards/specifications by recommending changes to Manager 10) Conduct hands-on-training for all QC chemists and technicians 11) Assist in preparing in-process, finished product and raw material specifications 12) Conduct documented job training for all QC personnel at least once a month 13) Audit laboratory records 14) Review and sign daily laboratory notebooks, daily laboratory activities test specification, daily receipt log and raw material logbook to order and maintain supplies necessary for designated areas 15) Ensure calibration of laboratory equipment and following up of preventive maintenance schedules 16) Maintain the Reference Standard Qualification Program for the site Requirements 1) Bachelor’s degree/equivalent formal training and experience 2) Minimum 3 years of experience in a cGMP QC or analytical laboratory 3) Experience in building and using databases (e.g. Microsoft Access) preferred 4) Superb knowledge of GMP principles 5) Proficiency in Microsoft Office software 6) Self-motivated with the ability to work independently when necessary, set goals, organize and follow project plans 7) Detail-oriented with through attitude towards things 8) Excellent communication (written and spoken) skills 9) Willingness to follow through on all aspects of a task for successful completion