**Overview** FUJIFILM Irvine Scientific, Inc.is hiring a Kitting Lead. The Kitting Lead will Facilitate and coordinate shop floor activities related to assigned area. FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation. **Shift:** 1st Shift: 5:00am-1:30pm **External US** **Responsibilities** • Reviews completed production lot folders for compliance with current regulations and company policies and procedures. • Assists personnel in daily production activities. • Reviews, suggest changes to production schedule to maximize personnel and process efficiencies. • Maintains adequate component and process supplies. • Assists in training of personnel in equipment setup / operation, maintenance and cleaning. • Reviews and maintains daily production and housekeeping logs. Routinely audit logs to ensure processes are performed per specifications. • Supports supervisor by helping to ensure all company policies and GMP regulations are adhered to by all individuals in the production areas. • Ensures all lot folder items such as line clearance procedures, unit / label accountability and Good Documentation Practices are being followed and appropriately. documented. Frequently navigates through electronic documentation systems to audit related processes. Reports concerns to shift supervisor. • Monitors lot folder data entry practices by production operators and provides training when necessary to eliminate data entry errors. • Monitors production equipment performance and reports issues and concerns to shift supervisor and / or department manager. • Suggests changes and improvements to SOPs and processes for compliance and process improvement. • Initiates Non-Conformance Reports (NCRs) and supports investigation for NCRs, customer complaints and CAPAs. • Coordinates activities between Supply Chain and Quality groups in relation to daily production schedule. • Completes SAP transactions related to batch records (material issuance, labor reporting). • Other duties as assigned by supervisor. **Required Skills/Education** • High School diploma, degree in chemistry or biochemistry preferred. • Good work history as a manufacturing lead or lead trainee in pharmaceutical / bio-tech. industries. • 1-2 years of liquid or powder formulation experience • Previous supervisory experience is a plus • General education • Working knowledge of metric system • Good understanding of Good Manufacturing Practices (GMPs) • Experience in operating computers and knowledge of Microsoft Office ® • Experience using ERP systems a plus • Ability to read and write English. • Spanish language fluency would be helpful in communicating with Production personnel but not required. • Good oral and written communication skills. **Salary and Benefits:** + For California, the base salary range for this position is $27.33-35.59 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.). + Medical, Dental, Vision + Life Insurance + 401k + Paid Time Off **EEO/AGENCY NOTES** Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law. To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid. *\#LI-Onsite **Job Locations** _US-CA-Santa Ana_ **Posted Date** _2 days ago_ _(12/13/2024 8:45 AM)_ **_Requisition ID_** _2024-32826_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Irvine Scientific, Inc._