Manufacturing Support Specialist

Manufacturing Support Specialist

The Manufacturing Support Specialist is a full-time exempt role supporting GMP manufacturing operations at Kashiv BioSciences, LLC, Chicago, IL. The Manufacturing Support Specialist provides comprehensive administrative, operational, and quality-system support to the Manufacturing department, reporting directly to the Manufacturing Manager. This role is responsible for authoring and lifecycle management of GMP documentation, such as Batch Records (BR), Deviations (DEV), Corrective and Preventive Actions (CAPA), Change Controls (CC), and trainings in alignment with internal procedures and regulatory expectations.

The Manufacturing Support Specialist plays a key role in ensuring compliant and efficient operations by partnering cross-functionally with Quality Assurance, Quality Control, MSAT, Engineering, and Supply Chain to drive timely closure of quality records, ensure data integrity, and support on-time delivery of manufacturing and quality milestones.

This employee must maintain effective employee relationships, compliance with cGMP and other regulatory and SOP requirements, as well as environmental, health and safety obligations and company policies.

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 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, 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. Cleanroom operational support may require working 1st shift or 2nd shift.
• 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 able to work with all levels of staff.

Position Requirements and 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 minimum 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 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 (08:30AM / 09:30AM to 05:00PM / 06:00PM). 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.

Benefits/Perks:

• Medical Insurance - Aetna
• Prescription Drug Converge | Rx
• Virtual Visits - Aetna/Teladoc
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSP
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits