Aug 04, 2022

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 Technical Expert is responsible for establishing and maintaining a culture of continuous improvement and Operations Excellence for the Quality Control department. This individual will provide front line support to QC related investigations as a Subject Matter Expert for raw materials, finished products and laboratory processes ensuring continued delivery of quality laboratory services while maintaining compliance to cGMPs, SOPs and FDA requirements.

• Responsible for preparing, executing, monitoring and updating the Quality Control Improvement Master Plan
• Works closely with the business unit managers to define and implement improvement plans and objectives that align to the Site Strategy
• Measures progress of results from improvement projects against the targeted Roadmap. Estimates and verifies financial benefits from continuous improvement projects
• Delivers proactive and effective communication related to improvement initiatives
• Drives visual management, data understanding for metrics and measurements which impact the total performance of the QC teams
• Develops an implementation plan, conducts risk assessments and develops contingency plans to accommodate unforeseen events. Recognizes and removes barriers to projects completion
• Assess current processes and standard work flow and identifies process improvement opportunities
• Collaborates with Operational Excellence to plan and facilitate the execution of various value stream mapping and Kaizen events, as needed
• Acts as a change agent by communicating the changes to the QC associates and helping them to learn, understand, adjust and grow within the continuous improvement culture
• Gives continued support in an effort to maintain laboratory output to meet specified deadlines/objective/metric expectations
• Ensure proper training curricula are implemented and updated periodically for the different QC teams
• Thinks strategically to anticipate future issues and challenges and create appropriate plans using proactive approaches
• Supports laboratory investigations demonstrating analytical capability to find systemic issues to root cause, and create action plans to mitigate risks
• Possess high knowledge of laboratory equipment, product/raw material and process trends
• Monitors quality audits outcome and collaborates with peers to facilitate and monitor the timely completion of corrective actions for findings
• Maintains processes and laboratory at inspection readiness level
• Helps monitor the compliance of Quality Control documentation and corrective actions
• Tracks and report progress of assigned projects for management. Ensure project documents are complete and current
• Supports and promotes the Company Standards of Ethics & Conduct as an essential element of the performance standards which is used in the overall performance ratings.
• Monitor for and promote Quality Culture and Novartis Behaviors for increased customer/quality focus.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and USP/NF etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Site, and Corporate Quality and Safety goals

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
• 5+ years of relevant experience in pharmaceutical industry is required

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
Melville, NY
Full Time
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QC Technical Expert

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