Job Description

Job Description Summary This position will be located at Morris Plains, NJ, and will not have the ability to be located remotely. The Quality Assurance Specialist is responsible for a first-level, hands-on, day-to-day cGMP facilitator role for all site-related GMP activities. They interact directly with site staff performing daily operational functions such as Make, Test, and Release, supporting the production of quality products. This role ensures the implementation of the quality strategy and promotes continuous improvement in product and process quality within the PU, QC labs, and other support areas. #LI-Onsite Key Responsibilities: # Shopfloor Activities: Conduct routine shop floor tasks related to aseptic operations, including ViMOS, APV observations, walkthroughs, QA area release, and QC Floor support. # Event Triaging: Manage deviations on the shopfloor for PU and QC laboratories, ensuring deviations are properly recorded in the deviation management system. # Review Activities: Review and audit production batch records and QC documentation to ensure compliance with Novartis policies, SOPs, and cGMP requirements. # Interface: Collaborate closely with PU and QC teams for batch record/QC data review, release, and resolution of compliance issues. # Process Improvement: Participate in initiatives aimed at achieving Right First Time (RFT) documentation and reducing deviations. # Documentation: Ensure documentation levels are adequate and compliant with existing procedures. # SOPs and Procedures: Write, review, and approve SOPs, Work Procedures, and Forms as needed. # Release Activities: Ensure timely review and release of Aphs, media batches, and area releases. # Final Product Release: Responsible for the final release of patient products, ensuring timely and compliant disposition in accordance with GMP and licensing requirements. Desirable Requirements: ~ BS/BA in Biological Sciences or relevant experience. ~3+ years of experience in a pharmaceutical environment. ~ Knowledge of cGMPs and current industry regulations. ~ Excellent communication skills. ~ Leadership and interpersonal skills. ~ Ability to work independently or in a team. ~ Preference for experience with SAP, 1QEM, MES, LIMS, deviation management, batch disposition, and aseptic techniques. Compensation and Benefits: The salary range is expected to be between $85,400 and $158,600/year, with potential adjustments based on market conditions and individual factors. The total package may include bonuses, stock units, and various benefits, including health, retirement, and paid time off. Final salary and benefits details will be provided upon offer. Note: The company will not sponsor visas, and relocation support is not available. Applicants must be able to access the Morris Plains location. EEO and Accessibility: Novartis is an Equal Opportunity Employer committed to diversity and inclusion. Reasonable accommodations are available for applicants with disabilities; contact us.reasonableaccommodations@novartis.com or call +1(877)395-2339 with your request. Salary Range: $85,400.00 - $158,600.00 Skills Desired: Continued Learning, Dealing With Ambiguity, GMP Procedures, QA, Quality Control Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence #J-18808-Ljbffr Novartis Group Companies

Job Tags

Remote work, Visa sponsorship, Relocation package,

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