Manufacturing Support Specialist

Kashiv BioSciences, LLC•Chicago, IL

9d•$65,000 - $70,000•Onsite

About The Position

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 training 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.

Requirements

Associate’s or Bachelor's degree in a scientific, technical, or related field
Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance
Minimum of 1-2 years of relevant experience in a GMP environment
Knowledge of GMP manufacturing required; biologics or biosimilars highly preferred
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
Collaboration and teamwork
Quality and compliance focused
Problem-solving and initiative
Accountability and reliability
Adaptability and flexibility

Nice To Haves

Biologics or biosimilars knowledge highly preferred

Responsibilities

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
Support initiation, investigation, and closure of Deviation records, including data gathering and technical writing of deviation narratives, and supporting root cause analysis (e.g., fishbone, 5-Why, 6M)
Execute and track CAPA activities, including documentation of actions, effectiveness checks, and timelines, and coordination with SMEs to ensure sustainable corrective actions
Support Change Control (CC) processes, including preparation of change documentation and impact/risk assessments, and identification of impacted systems, documents, and training
Partner with QA to ensure timely closure and audit readiness of records
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
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
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.
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.