QA Operations Sr Associate

329032BR
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?

Provide Quality Assurance support to packaging and compounding pharmaceutical manufacturing processes. Inspects, audits and reports on materials, processes, and products using variable or attribute measuring instruments and techniques to ensure conformance with the company's quality standards. This role will also provide support to the review of in process and finished product batch records to ensure conformance to established company procedures and government regulations prior to product release. Reporting of non-conformance to the appropriate personnel for reconciliation and investigation. Support MS&T, validation, and production activities

Major Accountabilities

• Closely monitoring and examining each stage of the entire production process.
• Perform daily walkthroughs for all Manufacturing Departments.
• Making sure that Manufacturing personnel follow documented procedures and standards.
• Inspects filling/packaging/labeling and other manufacturing operations to assure compliance with SOPs and cGMP.
• Performs visual inspections of packaging lines and equipment for cleanliness.
• Ensuring that the working area is hazard free and kept clean and tidy at all times.
• Reviews Manufacturing areas to include compounding and packaging equipment along with their relative equipment logbooks.
• Resolve quality-related issues in a timely manner on the production floor.
• Train the production personnel about quality concerns to ensure quality standards to include documentation.
• Performs visual inspections of compounding equipment for cleanliness.
• Performs and verifies daily calibration checks on scales for packaging and compounding areas.
• Verifies batch record information against packaging line set-up for filling operations.
• Assigns and close-outs appropriate Logbooks to manufacturing departments.
• Perform ERP transactions to support Manufacturing operations.
• Reviews and interprets batch record documentation and related material for accuracy and in accordance with SOPs and statutory governing regulations.
• Creates Certificates of Analysis as required
• Initiates correction of errors and omissions, and investigate non-conformances.
• Assigns expiration dates for product for packaging.
• Quality Management, as required, may assign and require other duties and responsibilities not previously mentioned above.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, 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.
• 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.

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
Hicksville, NY
Quality
Full Time
Regular
Yes
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329032BR

QA Operations Sr Associate

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