Kitting Lead - 2nd Shift

Responsibilities

• Reviews completed production lot folders for compliance with current regulations and company policies and procedures.
• Affords assistance to personnel in daily production activities.
• Reviews and suggests changes to production schedule to maximize personnel and process efficiencies.
• Maintains adequate component and process supplies.
• Affords assistance in training of personnel in equipment setup / operation, maintenance and cleaning.
• Reviews and maintains daily production and housekeeping logs.
• Routinely audits 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.
• Maintains oversight of lot folder data entry practices by production operators and provides training when necessary to eliminate data entry errors.
• Maintains oversight of 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.
• Collaborates with Supply Chain and Quality groups in relation to daily production schedule.
• Completes SAP transactions related to batch records (material issuance, labor reporting).
• Performs other duties as assigned by supervisor.

Requirements

• 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.

Qualifications

Salary And Benefits For California, the base salary range for this position is $24.17 - $31.42 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 Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (flbi@fujifilm.com).