QC Scientist - PM Shift

Job Description Summary

In this individual contributor role, the Quality Control Scientist will support patient throughput and compliance activities within the Quality department.

Job Description

Number of positions open: 2

Shifts Available:

Wed-Sat - Two PM positions open (3pm-3am)

Location: Morris Plains, NJ
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

Major Accountabilities

Patient Throughput

• Execute in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin.
• Perform data review, generate Certificates of Analyses for release of final produce in accordance with company procedure
• Work with cross-functional stakeholders to meet company timelines

Project Management

• Helps maintain progress of projects

Compliance

• Ensures that all planned, executed, and documented activities are aligned with company and site objectives.
• Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.

Support of Quality partners

• Assists Quality Control, AS&T, and Quality Assurance in investigations of assay-related issues.
• Executes and supports transfer of analytical methods between APS-QC, to other Novartis sites, and to CMOs.
• Provides timely response to requests for support of manufacturing deviations, investigations and change requests.

Other

• Performs or supports other tasks related to Quality and site operations, as needed
• Performs evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.

Key Performance Indicators

• Timely delivery on commitments and departmental KPIs
• Timely responses and solutions to analytical issues
• Compliance to all relevant company policies and guidelines

Ideal Background

Education :

BA, or MS in biology, chemistry, biochemistry, microbiology or other related science.

Languages:

English

Experience:

• Experience in Analytical Quality Control, method development, or a technical support function.
• At least 3 years of experience.
• Demonstrated knowledge and skills in multiple analytical techniques
• Understanding of ICH and FDA/EMEA GMP requirements
• Ability to prioritize and execute multiple tasks simultaneously under tight deadlines
• Strong verbal and written technical communication skills
• Strong interpersonal skill
• Proficiency using MS Word, Excel, and MS project
• Knowledge of cGMP, USP and FDA guidelines.
• Knowledge of LIMS systems.
• Knowledge of Quality Management Systems, such as Trackwise and 1QEM
• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
• Detail-oriented with ability towards problem solving and solid decision-making abilities.
• Strong written and verbal communication skills are essential.

Competency Profile

Specific Professional Competencies:

Internal orientation

• Thorough understanding of cGMP requirements
• Good communication and organizational skills
• Ensure customer satisfaction and react to customer requests
• Is seen as a competent team player
• Independent
• Results-driven and goal-oriented work ethic

Others

• Strong ability to work independently and compliantly
• Strong analysis and decision-making skills surrounding documentation
• Pays attention to detail
• Able to proof work and identify non-standard format or wording, and errors within documents
• Able to communicate with their management as well as other departments.

The pay range for this position at commencement of employment is expected to be between $85,400 and $158,600/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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.

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 +... and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$85,400.00 - $158,600.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence