Manufacturing Support Specialist

Manufacturing Support SpecialistThe 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:Technical Documentation and Documentation ManagementAuthor, revise, and review controlled GMP documents including Standard Operating Procedures (SOPs), batch records, and training materialsEnsure document accuracy, compliance, and alignment with internal quality standards and applicable regulatory requirementsManage document routing, approval workflows, version control, and archival within the documentation management systemQuality System ExecutionSupport initiation, investigation, and closure of Deviation records, including Data gathering and technical writing of deviation narrativesSupporting root cause analysis (e.g., fishbone, 5-Why, 6M)Execute and track CAPA activities, including Documentation of actions, effectiveness checks, and timelinesCoordination with SMEs to ensure sustainable corrective actionsSupport Change Control (CC) processes, including Preparation of change documentation and impact/risk assessmentsIdentification of impacted systems, documents, and training nPartner with QA to ensure timely closure and audit readiness of recordsProject and Deliverables ManagementTrack 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 performanceTraining and Onboarding SupportDevelop and maintain role-based training curricula and qualification matricesEnsure alignment of training content with approved GMP documentation and current processes.Support effectiveness of training through knowledge transfer and process standardizationManufacturing and Cleanroom SupportProvide 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-makingAssist with implementation of new systems, tools, and process improvements.Additional ResponsibilitiesWork 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 QualificationsEducation: Associate's or Bachelor's degree in a scientific, technical or related fieldBackground: Manufacturing, Process Engineering, MSAT, Technical Services, or Quality AssuranceExperience: GMP environment with minimum 1-2 years of relevant experienceKnowledge: GMP manufacturing required; biologics or biosimilars highly preferredSkills:o Technical writing abilityo Proficiency in Microsoft Word, Excel and PowerPointo Proficiency in electronic document or quality management systems highly preferredo Excellent oral and written communicationo Work effectively in fast-paced, cross-functional environmento Attention to detail and commitment to accuracyo Proficiency in electronic document or quality management systemsCompetencies:o Collaboration and teamworko Quality and compliance focusedo Problem-solving and initiativeo Accountability and reliabilityo Adaptability and flexibilityWorking Environment/Physical Requirements:General Work Environment: Office, laboratories, cleanroom manufacturing facilitiesNoise: 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 travelAdditional 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 bonusKashiv 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 | RxVirtual Visits - Aetna/TeladocHealth Savings Accounts (HSA)Flexible Spending Accounts (FSA)Dental Insurance - AetnaVision Insurance - VSPLife and AD&D InsuranceDisability BenefitsSupplemental Benefits Legal ServicesID Theft ProtectionTravel AssistanceValue Added Benefits & Services Health AdvocateLife Assistance Program (LAP)Student Loan Assistance Program401KMonthly Cell Phone AllowanceFree Parking (Company Paid)Conveniently located next to the Metra, Green and Red Line