QA Operations Specialist

About this role:

Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we're pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.

Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site.

Location:

Carlsbad, CA #

LI-OnsiteShift:

This position involves shift work which will be defined through site start up and commercialization readiness. 12-hour shifts and weekends will be required.

Key Responsibilities:

Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. Additionally, provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes.

Manufacturing support includes live batch record review and execution of AQL inspections.

Support continuous quality improvement initiatives for manufacturing operations by collaborating with production, QC, engineering, and supply chain teams to implement and optimize processes that enhance efficiency.

Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities, while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed.

Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.

Cross Train Expectations:

QA Batch Release:

Perform Master Batch Record approvals and issuance of batch records and labelsPerform Raw Materials release, updating statuses of materials in the ERP system.

Reviewing and approving raw material documentation and supplier CoAs to ensure quality and compliance of raw materials to be used in manufacturing processes.

Perform Final Batch Record Review and Final Product ReleasePerform a comprehensive review of all executed batch records and associated documentation to ensure compliance with specifications and regulatory requirements before product release.

QA ComplianceSupport the following programs as needed: Change Control Management, Customer Complaint Management, Document Control Management, Training Program Management, Supplier Qualification Program, Audit/Self-Inspection Program, Annual Product Quality Review (APQR),

Logbook IssuanceEssential RequirementsEducation:

Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree strongly preferred. 3+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations2+ years of experience in a quality assurance roleCollaborating across boundariesFunctional BreadthQA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zonesKnowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.

The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.