Quality Assurance Specialist

Roles and responsibilities include:

• Performing work under general supervision.
• Providing quality, technical support and oversight during manufacturing activities.
• Reviewing executed batch records and evaluating product and facility deviations; drawing conclusions in terms of product disposition at Spark.
• Opening deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; providing evidence of document closing at time of product disposition.
• Ensuring all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
• Reviewing and evaluating QC testing records and any associated OOS investigations.
• Reviewing, writing, revising, and approving SOPs, technical documents, and reports.
• Performing inspection and release of materials used for production and reviewing vendor certificates for completeness/compliance against approved specifications and collaborating with Material Management to release incoming materials for production.
• Compiling and maintaining metrics for testing results, quality documentation closure, and disposition and evaluating trending data to identify any irregular trends and notifying management as required.
• Providing administrative project management support for Quality Management System integration and improvement projects.
• Providing support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
• Supporting coordination of site Change Control Review Board and change control communications with third party license holder.
• Preparing 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 CAPAs, and identifying requirements to implement changes in a controlled GMP environment.

Education and experience:

• 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 a 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.