Scientist, Quality Control

2 weeks ago

Morris Plains, United States Novartis Full time

**About the Role**:
Location: Onsite - Morris Plains, NJ
Shift: Sunday - Wednesday 2:30pm - 1:00am
EVP: 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Scientist, Quality Control is an individual contributor role located in Morris Plains, NJ. The Quality Control Scientist will support patient throughput and compliance activities within the Quality department.
Your responsibilities include, but are not limited to
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

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 AS&T-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.

**Diversity & Inclusion / EEO**:

- We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._

**Role Requirements**:

- A minimum of a BA/BS in biology, chemistry, biochemistry, microbiology or other related science is required.
- At least 3 years of experience within pharmaceuticals of related testing laboratory is required
- Experience in Analytical Quality Control, method development, or a technical support function is required
- Demonstrated knowledge and skills in multiple analytical techniques is required
- Ability to prioritize and execute multiple tasks simultaneously under tight deadlines
- Strong verbal and written technical communication skills as well as strong interpersonal skill
- Detail-oriented with ability towards problem solving and solid decision-making abilities
- Strong written and verbal communication skills are essential as well as proficiency using MS Word, Excel, and MS project is required
- Understanding of ICH and FDA/EMEA GMP requirements
- Knowledge of cGMP, USP and FDA guidelines
- Knowledge of LIMS systems
- Knowledge of Quality Management Systems, such as Trackwise and 1QEM

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:

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: Novartis Talent Pool.

Division

Operations

Business Unit

QUALITY

Location

USA

Site

Morris Plains, NJ

Company / Legal Entity

Novartis Pharmaceuticals

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

Yes

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