Process Specialist

The Process Specialist is responsible for working directly with the operations team and providing support by identifying potential process improvements and procedural gaps. As well as performing processes improvements to address procedural gaps and champion process improvements. This position will also work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations and CAPA implementation. The Process Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. Additionally, they will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Identify and develop best practices/ SOPs to improve efficiency. Directs or conducts studies to ascertain the best sequence of operations or workflow. Experience with time studies, work measurement, engineering standards and data collections. Review employees and department productivity and partner with operations to develop action plans to improve performance. Maintain effective communication with other departments and employees. SME for processes related to preparation, formulation, and filling Strong change management skills to challenge the status quo and drive improvements. Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients. Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment. Ability to work with and influence peers and senior management. Self-motivated with critical attention to detail, deadlines and reporting Participate and support equipment/process FMEAs to understand process and product risks. Participate and report to a cross-functional team to advance project activities. Work flexible hours for the coverage of project demand. Other duties as assigned Initiate deviations and participate in operations investigations for determining root cause and assessing mitigation for deviating events. Support authoring, reviewing and approving of various SOPs & Work Instructions. Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity in batch records. Ability to manage multiple projects in a fast-paced environment. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Special Job Requirements: Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability Ensure compliance to regulatory requirements and industry guidance and requirements applicable to aseptic manufacturing, including FDA CGMP 21CFR;210/211, GMP Annex 1, ISO 13485 with awareness of industry trends, including FDA actions Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders. 4 years minimum experience working in a GMP environment. Excellent written and verbal communication skills. General computer skills evidenced by hands‑on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: 1-2 years demonstrated working knowledge of aseptic manufacturing operations. 1-2 years in a people leadership role #J-18808-Ljbffr INCOG BioPharma Services