Quality Assurance Specialist

Quality Assurance Specialist

Performs work under general supervision. Provides quality, technical support and oversight during manufacturing activities. Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark. Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition. Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release. Review and evaluate QC testing records and any associated OOS investigations. Review, write, revise, and approve SOP's, technical documents, and reports. Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production. Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required. Provide administrative project management support for Quality Management System integration and improvement projects. Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc. Support coordination of site Change Control Review Board and change control communications with third party license holder. Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials. Other assigned responsibilities as established by the QA Operations Lead. Ability to work and communicate with contract manufacturers and testing organizations. Ability to define problems, collect data, establish facts, and draw valid conclusions; Analysis and problem-solving skills, including but not limited to the ability to review and analyze manufacturing, quality control and validation data. Ability to participate on cross-functional teams in root cause analysis and solution identification. Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPA's, and identifying requirements to implement changes in a controlled GMP environment.

Bachelor's Degree in scientific discipline. Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field. Knowledge of Quality Systems such as Change Control, Investigations and CAPA. Ability to communicate effectively with wide range of personnel. Technical writing skills related to investigation reports. General working knowledge of relevant governmental regulations, cGMP and guidelines. Works under general supervision. Strong attention to detail. Ability to manage multiple priorities and tasks in a dynamic environment. Proficiency with computer programs. Ability to work effectively in a team environment. Ability to establish facts, define problems, collect data and draw valid conclusions. Ability to exercise judgment to determine appropriate corrective actions. With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations Excellent written and verbal skills.