Supply Chain Production Planner

MillenniumSoft Inc; San Jose (CA); On-site; USD 28,000 - 34,000; Full time

Job summary

Millenniumsoft is seeking a Supply Chain Production Planner for a 9+ month contract in San Jose, CA. The role requires coordination with manufacturing to ensure readiness during product phase in/out, and managing documentation within SAP and Documentum for IVDR compliance.

The candidate should have a biology background, experience in regulated manufacturing, and strong documentation and communication skills to support regulatory submissions and data loads.

Qualifications

• Requires a Bachelor’s degree in biological sciences and 1 year of experience in a manufacturing or laboratory environment.
• Prior experience in a FDA or ISO medical device regulated manufacturing environment desirable.
• Knowledge of GMPs and regulatory requirements.

Responsibilities

• Create and update manufacturing documents (Specifications and procedures) and master data (BOMs and routings) impacted by the IVDR program; prepare and submit ACRs and ECRs.
• Coordinate with Planning and Manufacturing to ensure readiness for phase out of old versions and phase in of new versions of products with labeling and packaging changes.
• Review documents in Documentum, SAP and other archives to gather and summarize data to support regulatory submissions.
• Provide data for PIM/ EuDaMed data load and ongoing maintenance.
• Assist in tasks to support IVDR and Reagent Operations.

Skills

Documentation

Communication

Organization

Education

Bachelor’s degree in biological sciences

Tools

SAP

Documentum

Job description

Job Title - Supply Chain Production Planner

Location - San Jose, CA

Duration - 9+ Months Contract

pay rate: $20-25/hr

1st Shift: Work hours: Standard schedule; onsite, 8a-5pm

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Description

• Create and update manufacturing documents (Specifications and procedures) and master data (BOMs and routings) impacted by the BDB EU and non-EUIVDR program. Prepare and submit ACRs and ECRs. Work with LDUID (iDev) and other functions to collect information, monitor, analyze and update status until completion.
• Coordinate with Planning and Manufacturing to ensure manufacturing readiness of phase out of old versions and phase in of new versions of products in the implementation of labelling and packaging changes. Perform regulatory impact assessment for label change implementation.
• Work in Documentum, SAP and other document archives to gather and review available documentation. Retrieve, compile, summarize manufacturing and QC test data in reports to support IVDR Technical Document and international regulatory submissions.
• Provide data and information to support the PIM/ EuDaMed data load and ongoing maintenance.
• Perform other tasks as assigned to support IVDR and Reagent Operations.

Education And Experience

• Requires a Bachelor’s degree in biological sciences and 1 year of experience in a manufacturing or laboratory environment or related business/industrial experience.
• Prior experience in a FDA or ISO medical device regulated manufacturing environment and knowledge of medical device documentation, product labeling, manufacturing and business process are desirable.
• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• General knowledge of Microsoft Word and Microsoft Excel, and the ability to learn and function competently within SAP software environment.
• Requires good documentation (maintaining clear and concise records) and effective communication
• The preferred candidate will demonstrate excellent organizational skills, and the ability to manage multiple/changing priorities and effectively work in a team environment