QC Sample Management Technician

Job Description Summary

The QC Sample Management Technician reporting to the QC Supervisor – Sample Management will support lab operations by performing routine sample management to support Quality Control (QC) Analytical laboratories.

 

Job Description

Shift: Sun-Wed AM

Hours: 7:00am - 5:30pm

Location: Morris Plains, NJ

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

Core Responsibilities:

• QC sample / retains sample handling including receival, registration, storage, distribution and destruction
• Delivering samples to QC laboratories for testing as required
• Preparation of samples for shipment
• Performing sample inventory and disposal
• Ensure samples and materials are appropriately labelled and maintain sample tracking, labelling and chain of custody records in accordance with regulatory requirements and written procedures.
• Maintain the Sample Retain inventory room, refrigerators, and freezers.
• Ensure that Sample Retains are stored in appropriate locations.
• Ensures adequate storage areas are available in each sample storage area.
• Ensure Sample Retains are readily available for Shipping with proper documentation. Prepare for shipping testing to contract labs for chemistry and microbiology samples.
• Dispose of Sample Retains in accordance with cGMP regulations after retention time has passed.
• Organize Sample Retains by lot/batch number, documenting the storage location in logbooks/excel for ease of retrieval.
• Performs other related duties as assigned.

Continuous Improvement:

• Drive a culture of continuous improvement and proactively identify opportunities for efficiency enhancements and process improvements within the Quality Control procedures.

Collaboration:

• Interacting with outside customers and functional peer groups
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Support investigation of sample management-related issues: Work together with QA and Investigation/Compliance personnel and with stakeholders on addressing any non-compliance or sample management-related deviations, implementing corrective actions, and documenting findings.

Compliance:

• Ensure that sample management activities are completed in compliance with all applicable procedures, standards and GMP regulations.

Key Performance Indicators:

• Timely delivery on commitments with and departmental KPIs
• Timely responses and solutions to training-related issues
• Efficient and flexible usage of the available resources
• Compliance to all relevant company policies and guidelines
• Exhibiting core Novartis values and behaviors and fostering these within the team

Ideal Background:

Education:

• HS diploma, Associate’s degree, Biotechnology certificate, or Bachelor’s degree in biology, chemistry, or other related degree concentration

Languages:

• English

Experience:

• 0-2 years of experience in a cGMP environment / commercial manufacturing.
• Experience in a regulated GMP environment, preferably within QC operations in a cell therapy company.

Skills:

• Experience with handling Liquid Nitrogen (LN2) samples
• Experience with use and routine maintenance of sample handing equipment including BSCs, refrigerators, freezers and LN2 storage tanks.
• Experience with pipetting and aliquoting
• Experience with electronic laboratory management systems (such as LIMS)

Competency Profile:

• Strong communication skills for interacting with a variety of collaborators and partner groups
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Ability to function in a rapidly changing environment & handle multiple priorities.
• Ability to collaborate cross functionally to drive operational and quality excellence.
• Advanced organizational and time management skills.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Customer service mindset
• Continuous improvement mind frame
• Highly organized