Production Lead - Powder - 3rd Shift

Overview

Position Description

We are hiring a Production Lead
- Powder. The Production Lead
- Powder, under the Production Supervisor’s direction, will coordinate efforts associated with the safe execution of Liquid Media manufacturing, Powder Media manufacturing or Kitting Assembly activities. They will assign tasks to department personnel, provide training of subordinates on job specific, GMP and Safety procedures and review production lot folders for correctness.

Company Overview

At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences).

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

• 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.

• 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…