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

Major accountabilities:

Position Summary

Support lab operations by performing routine QC in-process and release test sample and QC retain sample management to support Quality Control (QC) Analytical laboratories.

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 with an attention to detail

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

The pay range for this position at commencement of employment is expected to be between $63,600 and $118,200/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patient and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$63,600.00 - $118,200.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management