Overview

Reporting to the Materials Operations Manager, the primary role of the Materials Operations Bio Technician will be the day to day operation of the warehouse, sampling and materials dispensary operations on-site.
Coupled with this, the Materials Operations Bio Technician will also be responsible for preparing the on-site warehouse and any off-site storage for GMP operation as part of the Shanbally facility start up.
This role requires flexibility with regards to work schedules and shift work may be required to support business needs.
This role will operate within a team environment with an emphasis on safety and quality and will be committed to continuous improvement, teamwork, personal development and delivery of best in class service in support of Drug Substance manufacturing operations at the Shanbally facility.

RESPONSIBILITIES

Demonstrate an active approach to safety, industrial hygiene, environmental, cold chain management and GMP/GDP compliance
Receiving, inspection, labelling, booking and put away of all inbound inventory
Sampling of GMP material as per approved sampling plans
Dispensing, weighing and kitting of raw materials and consumables to support Manufacturing schedule on a day to day basis
Manage Kanban system to support manufacturing operations
Execute outbound shipments as per schedule including responsibility for all required documentation and scheduling of freight forwarders
Oversee the environmental monitoring of both ambient and cold storage areas reporting and resolving any deviations through the relevant quality system
Key user of Oracle ERP system, specifically materials management modules
Manage inventory tracking program designed to maintain accurate inventory tracking (on-site & off-site), including cycle counting
Implement corrective actions to ensure performance targets are consistently met and continuous improvement is demonstrated through KPI’s
Oversee day to day interactions with vendor managed inventory provider on site
Participate in regulatory inspections as SME in Materials Operations
Working flexible shift patterns to meet business needs and Manufacturing schedule

CONTACTS

Work closely with Quality Operations, Facility Services, Manufacturing and Supply Chain personnel to ensure efficient Materials Operations. Interact with Materials Management group in Novato California.

Skills:

EXPERIENCE

Minimum 3 years’ experience working in GMP warehouse environment.
Biopharmaceutical experience is desirable.
Materials sampling, dispensing, weighing & kitting experience essential.
Experience of GMP warehouse start up is preferable.
Strong systems experience, Oracle preferably.
Experience in product shipments and hazard material/waste handling is preferable.
Forklift (counter balance and stacker) experience is preferable.
Strong demonstrated ability in communicating and interacting across cross-functional teams.
Demonstrated ability in implementing continuous improvement projects to deliver operational excellence.
Experience with regulatory inspections.

Education:

EDUCATION