343068BR
May 24, 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 Specialist 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. Under the direction of the Manager/ Supervisor, may supervise and give direction to others.
Your responsibilities include, but are not limited to:
• Proficiently conducts more technically advanced analyses (e.g. degradation assays, R&D stability studies) concerning chemistry of drug products, raw materials, components and processes for purposes of product and process development, quality control, quantitative and qualitative analysis.
• Perform analytical testing to ensure compliance with FDA and cGMP requirements according to approved written procedures and specifications.
• Instrumentation includes those of a high level of complexity and difficulty (e.g. GC and HPLC)
• Prepares test data for appropriate review.
• The individual should be self-motivated with a well-developed knowledge of HPLC/GC problem solving and troubleshooting.
• 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 color 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

• BS or higher in Chemistry or related field
• Minimum of four (4) years pharmaceutical, chemical or related experience
• Maintains the flow of information within the department.
• Professionally interacts with Quality Control Department and Management, Quality Assurance, and other departments.
• Under the direction of the Manager/Supervisor, may supervise and give direction to others.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Strong written and oral communication skills are required.
• Extensive knowledge of Laboratory Procedures is required.
• While performing the duties of the job the employee is frequently required to sit.
• The employee is occasionally required to lift up to 50 pounds.

The physical demands described here are representative of those that must be met by an employee to successfully preform the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.
Novartis Technical Operations
NTO QUALITY
USA
Melville, NY
Quality
Full Time
Regular
Yes
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343068BR

QC Analyst, Specialist

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