Quality Assurance Specialist

/n/nPrimary Duties
The Quality Assurance Operations Specialist will:
• Performs work under general supervision.
• Provide 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.

Education and Experience Requirements
• 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.

Key Skills, Abilities, and Competencies
• 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;
• Ability to work and communicate with contract manufacturers and testing organizations.

Complexity and Problem Solving
• 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

Internal and External Contacts
• Peers and colleagues throughout the organization as well as external, including manufacturing, Quality Control, facilities and vendors.