Senior Quality Systems Specialist - Randstad : Job Details

Onsite in Bedford, MA 4 days per week. Immediate opening for a Quality Systems Senior Specialist. Responsible for overseeing several aspects of the Quality System including documenting and investigating Customer Quality Complaints, coordinating Annual Product Quality Reports (APQR), performing internal audits and inspection walkthroughs to promote external audit readiness, and execute gap assessments of current procedures and processes. Other functional re[ \n\t. Bachelor of Science in a technical discipline or equivalent combination of education and experience.\n\t. Minimum of five (5) years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.\n\t. Demonstrated knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.\n\t. Proficient in conducting GMP compliance audits in a pharmaceutical GMP compliance organization.\n\t. Experienced in investigating Customer Product Quality Complaints, effectively communicating...Quality, Systems, Specialist, Senior, Technology, Staffing