Quality Assurance Specialist

Analytical Quality Assurance SpecialistThe Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Working in a team environment, the AQA Specialist will provide oversight to ensure that all testing is performed in accordance with applicable procedures and compliance standards, ensure Data Integrity is maintained at all times, provide coaching and problem resolution from a Quality Assurance perspective, and act as primary reviewer of QC data for batch disposition. The AQA Specialist must be well organized and detail oriented, ensure quality events are raised in a timely manner as required.Responsibilities:Ensure QC processes are controlled and monitored and identify and troubleshoot any quality issuesMonitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicableSupport in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocolsDocument activities with internal reportingIdentify training needs and take action to ensure company-wide complianceResponsible for the compilation and interpretation of QC Analytical data including OOSResponsible to ensure that established testing control procedures and good documentation practices are followedEnsure compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDAEducation:Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalentExperience:2 – 3 years in Quality Control, or equivalentKnowledge and Skills:Excellent analytical skillsStrong knowledge of CFRsStrong interpersonal skillsExcellent verbal and written communication skillsAbility to work well in a team environmentAbility to work independentlyStrong problem-solving skillsStrong organizational skillsQuality certifications or training a plus