Material Handler II

Location:  Novato, California Category: Manufacturing

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Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Role
The purpose of the Material Handler 2 is to ensure raw materials are ready and available at Novato site in order to support the Commercial and Clinical Manufacturing Facilities. 
The position may require off hours support as required.  The position will require shift-work, including weekends, off hours and holidays.
 
GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.
 
Key Responsibilities 
Material Handler 2 will be responsible for sampling, weighing, and dispensing raw materials to produce buffer, solution, and media kits for manufacturing facilities.  Material Handler 2 is also responsible for receiving and verifying materials and ensuring that material storage locations are properly stocked and maintained.  Responsibilities include, but are not limited to the following:
 
·         Receives, verifies and coordinates raw material receipts and returns from warehouses to manufacturing facilities and vice versa.
·         Contact for raw material issues and reconciliation.
·         Coordinates and reconciles raw materials that are in Quarantine.
·         Performs audit of commonly used items to ensure inventory accuracy.
·         Coordinates a removal of expired raw materials and expired in-process inventory.
·         Maintains accurate inventory records for approved GMP raw materials, components and supplies.
·         Performs cycle counts of approved GMP material inventory as assigned using ERP system.
·         Complies with EHS&S safety guidelines, especially those directly related to the operation of warehousing equipment such as pallet jacks and forklifts.
·         Performs pre-weigh for Kitting of buffers, solutions, and media.
·         Performs sampling of raw material chemicals.
·         Maintains warehouses and sub-inventory areas in an audit ready state.
·         Complies with cGMP Documentation, Practices and Regulations.
·         Transports and distributes approved GMP raw materials, components and supplies to the designated manufacturing facilities.
·         Participates with SOP and Work Instruction updates as required.
·         Provides suggestions for process improvements and participate in implementation.
·         Manages Kanban system to support manufacturing operations.
·         Required to work in a clean room environment.
·         Demonstrates the concepts of the network neighborhood.
·         Inputs data for trending defined metrics.
·         Assists with performing training activities.
·         Assists with action items assigned during deviation investigations, corrective/preventative actions (CAPAs), and change requests.
·         Other duties as assigned.
  

EXPERIENCE

Required Skills:

  • Proficient in Microsoft Office applications.
  • Ability to follow Standard Operating Procedures (SOP).
  • Must possess a valid California driver’s license.
  • Effective written and verbal communication skills.
  • Detail oriented.

Desired Skills:

  • 1-2 years experience in a GMP warehousing environment.
  • Demonstrated leadership skills.
  • Knowledge in MES, SAP, Oracle EBS, CMMS, Veeva and LabWare LIMS systems or similar operating databases.
  • Experience in continuous improvements.

EDUCATION

  • High School Diploma or equivalent required.
  • AA/AS or BA/BS in Life Sciences or related discipline preferred.

EQUIPMENT

  • Class C trucks
  • Pallet jacks
  • Forklifts (Narrow-aisle and fork-truck style lifts)
  • Floor Scales and other measuring equipment
  • LAF hoods
  • Scan guns

WORK ENVIRONMENT/PHYSICAL DEMANDS

  • Consists of strenuous, repetitive work.  The following list of physical movements may be used on a daily basis: pulling, pushing, bending, reaching, climbing stairs and ladders, and kneeling.
  • Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 30 pounds.
  • May require work around loud equipment.
  • The use of personal protective equipment will be required.
  • Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

REQUIRED WORK HOURS
Sunday - Wednesday. 7am - 6pm PST

CONTACTS

Work closely with Quality Operations, Facility Services, Manufacturing and Supply Chain personnel to ensure efficient supply of raw materials.

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