With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Education:Manufacturing operations experience must have been in an FDA regulated environment (Bio-Tech / Pharma / Medical Devices) Experience in Quality Record management is required. This implies Non-Conformances (Deviations), CAPAs, CAPA EVs, Change Control records, etc.
Requirements:The Manufacturing Specialist will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories).The Specialist is expected to execute nonconformance, CAPA, CAPA-EV, SICAR, EN, Change Control and metrics oversight responsibilities. The Specialist processes, investigates and acts as first responder to deviations. Addresses and expedites product and raw material deviation under the company's quality management system procedures, and ensures compliance with regulatory agencies. Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses. Maintains unified product defect investigation operating procedures. Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent re-occurring events. Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. May serve as the primary point of contact between External Supply and the site teams as well as External Supply Quality to ensure the quality of raw materials used at the sites.
Job Type: Contract
Juncos, PR (Preferred)
English and Spanish (Preferred)