Manufacturing Support Specialist

Position Summary Manufacturing Support Specialist is a full‑time exempt role supporting GMP manufacturing operations at Kashiv BioSciences, LLC, Chicago, IL. Essential Duties And Responsibilities Key responsibilities of the position include, but are not limited to: Technical Documentation and Documentation Management Author, revise, and review controlled GMP documents including SOPs, batch records, and training materials. Ensure document accuracy, compliance, and alignment with internal quality standards and applicable regulatory requirements. Manage document routing, approval workflows, version control, and archival within the documentation management system. Quality System Execution Support initiation, investigation, and closure of Deviation records, including: Data gathering and technical writing of deviation narratives. Supporting root cause analysis (e.g., fishbone, 5‑Why, 6M). Execute and track CAPA activities, including: Documentation of actions, effectiveness checks, and timelines. Coordination with SMEs to ensure sustainable corrective actions. Support Change Control (CC) processes, including: Preparation of change documentation and impact/risk assessments. Identification of impacted systems, documents, and training. Partner with QA to ensure timely closure and audit readiness of records. Project and Deliverables Management Track and drive on‑time completion of manufacturing and quality deliverables, including batch documentation, DEV, CAPA, and CC. Maintain visibility of departmental KPIs (e.g., right‑first‑time, deviation closure timelines, training compliance). Support continuous improvement initiatives by identifying trends in DEVs, CAPAs, and production performance. Training and Onboarding Support Develop and maintain role‑based training curricula and qualification matrices. Ensure alignment of training content with approved GMP documentation and current processes. Support effectiveness of training through knowledge transfer and process standardization. Manufacturing and Cleanroom Support Provide hands‑on operational support in GMP cleanroom environments during peak demand or special projects. Ensure strict adherence to aseptic technique, gowning, and cleanroom procedures. Provide daily administrative support, including scheduling, coordination of activities, and preparation of reports. Assist with tracking departmental metrics and compiling data to support operational decision‑making. Assist with implementation of new systems, tools, and process improvements. Additional Responsibilities Work with operations team to create a culture of accountability, ownership, and continuous improvement. Respect all safety, laboratory policies, and practices on site. Work across departments and/or sites. Work with process engineers and leadership to align the priorities of the team with those of the department. Able to work independently; shows initiative and is able to work with all levels of staff. Requirements Education: Associate’s or Bachelor’s degree in a scientific, technical, or related field. Background: Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance. Experience: GMP environment with a minimum of 1‑2 years of relevant experience. Knowledge: GMP manufacturing required; biologics or biosimilars highly preferred. Skills: Technical writing ability. Proficiency in Microsoft Word, Excel, and PowerPoint. Proficiency in electronic document or quality management systems. Preferred Excellent oral and written communication. Work effectively in a fast‑paced, cross‑functional environment. Attention to detail and commitment to accuracy. Proficiency in electronic document or quality management systems. Competencies: Collaboration and teamwork. Quality and compliance focused. Problem‑solving and initiative. Accountability and reliability. Adaptability and flexibility. Working Environment / Physical Requirements General Work Environment: Office, laboratories, cleanroom manufacturing facilities. Noise: No extraordinary noise levels. Standing/Lifting: Must be able to move around the facility to reach various equipment and lift at least 25 lbs. Visual: No extraordinary requirements. Stress: High‑paced, demanding environment to meet ambitious project goals. Travel: Limited travel. Additional Position Information Support Specialist hours: Office Hours (08:30 AM / 09:30 AM to 05:00 PM / 06:00 PM). Overtime, holidays, and weekends may be required based on requirements. Manufacturing Production shift hours: Shift A (first shift): 06:00 AM to 2:30 PM EST, Shift C (second shift): 2:00 PM to 10:30 PM EST, and Shift D (third shift): 10:00 PM to 6:30 PM EST. Overtime, holidays, and weekends may be required based on requirements. Compensation: This is an exempt FTE position. Manufacturing Support Specialist (1-2 years of experience): $65,000–70,000 with up to 5% discretionary bonus. Kashiv BioSciences is able to provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future. Interviews and employment are conducted onsite at our Chicago, IL facility. Candidates should currently reside within a reasonable commuting distance or be planning to relocate to the area. Supervisory Responsibility No. Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training. #J-18808-Ljbffr