Production Lead - Liquid - 3rd Shift

Fujifilm•Santa Ana, CA

1d•Onsite

About The Position

The Production Lead- Liquid, 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. This is a 3rd shift position, working from 9:00pm to 5:30am.

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
General education
Working knowledge of metric system
Good understanding of Good Manufacturing Practices (GMPs)
Experience in operating computers and knowledge of Microsoft Office ®
Ability to read and write English.
Good oral and written communication skills.

Nice To Haves

Previous supervisory experience is a plus
Experience using ERP systems a plus.
Spanish language fluency would be helpful in communicating with Production personnel but not required.

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.