347755BR
Aug 02, 2022
USA

Job Description

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry!

The Data Review, Senior Associate is responsible for complying with the company's Quality Control efforts. This includes the review of Laboratory Notebooks, Results Entry and Verification and the review of Chromatographic data to ensure that Laboratory activities are performed to support SOPs, GMP and FDA requirements and are consistent with laboratory objectives.

• Highly knowledgeable of Equipment, product/raw material and process trends.
• Perform first line review of analytical testing performed in the Quality Control Laboratory to ensure compliance to cGMP/FDA standards.
• Accurate review of documentation including, but not limited to, Laboratory Notebooks, Results Entry/Verification, Empower Chromatographic Data (GC and HPLC), Pre-Printed Notebook templates.
• Approve Finished Product, Stability, Complaint, Cleaning Validation and/or Raw Material and non-routine batches upon successful completion of QC release testing.
• Proficiently conducts review of electronic data including, but not limited to Chromatographic Data (Empower), IMS, LIMS and Digital Microscopy data when required.
• Assess and Trend Analytical data where applicable
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
• Monitors for and promotes Quality Culture and Novartis Behaviors for increased customer/quality focus.
• Quality Management, as required, may assign and require other duties and responsibilities not previously mentioned above.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

To perform this job successfully, an individual must have satisfactory visual acuity and col-or perception. Visual acuity and color blindness screenings may be used to screen applicants.

• Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.
• Satisfactory color vision means ability to recognize traffic signals and devices showing the standard red, green, and amber traffic signals.

Diversity & Inclusion / EEO

The Novartis Group of Companies 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.

Minimum Requirements

• Bachelor's Degree in Chemistry or related scientific field is required
• 4+ years of relevant experience in the pharmaceutical industry is required

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients 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

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
Novartis Technical Operations
NTO QUALITY
USA
Melville, NY
Quality
Full Time
Regular
No
careers default image
347755BR

Senior Associate, Data Review

Apply to Job Access Job Account