QC Analyst, Senior Associate

328812BR
USA

Job Description

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?

Job Purpose

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.

Major Accountabilities

• Proficiently conducts quantitative and qualitative analyses of drug products, com-ponents 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 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.

Key Performance Indicators
• Professionally interacts with Quality Control Department and Management, Quality Assurance, and other departments as required.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Strong analytical skills.
• Strong mathematical skills.
• Strong computer skills.
• Attention to detail.
• Ability to multitask and adapt to changing priorities.
• Possesses initiative and trouble shooting ability.
• Should possess initiative, inquisitiveness and the ability to solve scientific problems.
• Must be able to work on multiple projects at once. The individual should be self-motivated.
• 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. Reasona-ble accommodations may be made to enable individuals with disabilities to perform the essential functions.


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

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.
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Novartis Technical Operations
NTO QUALITY
USA
Melville, NY
Quality
Full Time
Regular
No
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328812BR

QC Analyst, Senior Associate

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