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Job #03223

About our client Our client is a privately owned biotech company headquartered in Florida that is focused on the development and commercialization of products in the area of oral healthcare. The company has an experienced management team, a robust line of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance/Quality Control Manager Gainesvilles, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Implement, sustain and improve the quality management system as well as ensure that a clear quality approach and mindset is implemented throughout the company 2) Conduct management reviews and ensure escalation of quality issues to appropriate management for resolution 3) Implement and sustain ISO, FDA as well as other registrations and certifications 4) Facilitate design and process risk analyses (e.g. FMEAs), reviews as well as endorse design and manufacturing process validations/verifications 5) Devise and implement methods and procedures for inspecting, testing and evaluating production 6) Review product design and labeling to ensure compliance with applicable regulatory requirements 7) Oversee product release to ensure compliance with product specifications 8) Provide technical quality support to internal and external manufacturing area(s) 9) Evaluate and organize audits (internal, external, customer and product) and initiate corrective actions (as necessary) 10) Ensure that all Inspection, Measurement and Test Equipment (IMTE) used to verify product quality are periodically calibrated as well as protected/maintained for use 11) Control and maintain the documentation associated with the quality system and the products that are designed, developed, produced and released for distribution by the company 12) Ensure compliance to company quality management system elements including oversight of change control, CAPA, nonconformance, supplier quality management and finished product release 13) Develop and conduct training in quality systems procedures to enhance efficiency and compliance (i.e. product/component disposition, non conformance system, CAPA and device history records/retention) 14) Monitor and analyze supplier and/or internal performance and nonconforming product data to identify products or processes requiring quality improvements 15) Determine and implement the appropriate corrective actions 16) Perform internal and/or supplier audits (supplier management) 17) Maintain the complaint system and ensure that complaints are processed to determine if specifications or intended use was not met (and if not, process failures for root cause analysis and corrective action) 18) Participate in complaint reviews and lead customer complaint investigations 19) Supervise all product and raw material testing as well as ensure all necessary control tests are performed utilizing standard test procedures to allow product shipments within established guidelines 20) Establish work priorities for and evaluate work performance of QA/QC technicians 21) Ensure that QA/QC technicians are properly trained in accordance with established procedures 22) Generate certificates of analysis and certificates of compliance and ensure that they are provided to customers (as appropriate) 23) Perform other duties as assigned by management Requirements 1) BS in Engineering, Science or equivalent academic credentials 2) CQE/CRE/CQM certification through ASQC environment 3) ISO Lead Auditor or auditor training 4) Minimum 5 years of experience in a quality function within a pharmaceutical or excipient manufacturing 5) Experience in creating and overseeing process validations (IQ, OQ and PQ) 6) Demonstrated experience in quality system regulations (e.g. FDA QSR, cGMP, EU ISO13485, ISO9001, etc.) 7) GMP experience