Manufacturing Support Specialist

About the role

The Manufacturing Support Specialist is a full-time exempt role supporting GMP manufacturing operations at Kashiv BioSciences, LLC, Chicago, IL.

Responsibilities

• Technical Documentation and Documentation Management
• Author, revise, and review controlled GMP documents including Standard Operating Procedures (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
• Data gathering and technical writing of deviation narratives
• Support root cause analysis (e.g., fishbone, 5-Why, 6M)
• Execute and track CAPA activities
• Documentation of actions, effectiveness checks, and timelines
• Coordination with SMEs to ensure sustainable corrective actions
• Support Change Control (CC) processes
• Preparation of change documentation and impact/risk assessments
• Identification of impacted systems, documents, and training needs
• 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
• Aid in tracking departmental metrics and compiling data to support operational decision-making
• Aid in implementing 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

Qualifications

• 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 highly 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, if any: No