Manufacturing Support Specialist

Description

SUMMARY:

The Manufacturing Support Specialist is a regular employee in a full-time exempt position 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. 

The Manufacturing Support Specialist plays a key role in ensuring compliant and efficient operations by supporting responsibilities such as GMP documentation management (batch records, SOPs), training coordination, quality-system support (Change Controls, CAPAs, Deviations), and cleanroom manufacturing assistance as required. This employee supports success of the department’s projects/activities and ensure on-time deliverables to meet company commitments. 

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:

Administrative and Departmental Support

• Provide daily administrative support to the Manufacturing Manager, including scheduling, coordination of activities, and preparation of reports
• Facilitate communication between Manufacturing and cross-functional departments such as Quality Assurance, Quality Control, Supply Chain, and Facilities
• Assist with tracking departmental metrics and compiling data to support operational decision-making

Documentation Management

• Draft, 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 

Training and Onboarding Support

• Assist in the development, coordination, and delivery of training for new and existing employees. 
• Support onboarding activities, including orientation documentation, training assignments, and competency tracking. 
• Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team. 

Quality System Support

• Support Corrective and Preventive Action (CAPA) activities, including data collection, documentation, tracking, and follow-up.
• Assist with investigations by gathering relevant data, compiling summaries, and supporting root-cause analysis efforts.
• Contribute to change control processes by preparing or updating impacted documents, tracking deliverables, and ensuring timely completion.
• Participate in internal audits, compliance reviews, continuous improvement initiatives, and regulatory inspections as assigned.

Manufacturing and Cleanroom Support

• Provide hands-on support in cleanroom operations during periods of increased demand, staffing gaps, or special projects. Cleanroom operational support may require working 1st shift or 2nd shift. 
• Adhere to all cleanroom, gowning, aseptic, and safety procedures.
• Assist with production activities, equipment setup, material handling, and other operational tasks as assigned

Cross-Functional Support 

• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
• 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.

Requirements

REQUIREMENTS:

Education and Experience

• Associate’s or Bachelor's degree in a scientific, technical or related field
• Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance preferred
• At least 2 years of related experience in a GMP manufacturing environment

Knowledge, Skills, and Abilities

• Knowledge of GMP manufacturing, required. Knowledge of biologics or biosimilars preferred.
• Excellent oral and written communication skills required. Technical writing ability and document editing skills preferred. 
• Ability to work effectively in fast-paced, cross-functional environment
• Strong attention to detail and commitment to accuracy 
• Proficiency with standard office software, experience with electronic document or quality management systems preferred. 

Core 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 40lbs.
• Visual: No extraordinary requirements.
• Stress: High-paced demanding environment to meet ambitious project goals.
• Travel: Limited travel

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.