344420BR
May 13, 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 Quality Control Analyst Senior Associate is responsible for complying with the company's Quality Control efforts. This includes the performance of area responsibilities necessary to ensure that Laboratory activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with laboratory objectives.

• Proficiently conducts quantitative and qualitative analyses of drug products, components and processes for purposes of product and process development.
• Test samples to ensure compliance with FDA and cGMP requirements according to approved written procedures and specifications.
• Instrumentation includes those of a basic (i.e. pH meter, microscope, UV/Vis Spectrophotometer, FT-IR, viscometers, density meters) to a high level (i.e. GC and HPLC) of complexity and difficulty.
• Prepares test data for appropriate review.
• Documents the procedures and results obtained in laboratory notebooks according to established regulatory guidelines.
• Assists in calibration and maintenance activities of instruments used in analyses.
• 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 in these subjects as per applicable local, state and/or federal regulations.
• 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

• Bachelors Degree in Chemistry or related scientific field is required.
• Advanced Degree is preferred.
• 2+ years of relevant experience is required.
• Previous experience in the pharmaceutical industry is preferred.

Why consider Sandoz:

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine!

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
344420BR

QC Analyst, Senior Associate (Raw Materials)

Apply to Job Access Job Account