QA Operations Specialist

Job Description Summary

About this role:

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-Onsite

Shift:
This position involves shift work which will be defined through site start up and commercialization readiness.

Job Description

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 labels
• Perform 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 Release
• Perform a comprehensive review of all executed batch records and associated documentation to ensure compliance with specifications and regulatory requirements before product release.

QA Compliance:

• Support 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 Issuance

Essential Requirements

• Education: Bachelors Degree preferably in Life Sciences Chemistry or related relevant degree strongly preferred
• 2 years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations
• 1 years of experience in a quality assurance role
• Collaborating across boundaries
• Functional Breadth
• QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones
• Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.

The salary for this position is expected to range between $81200 and $150800/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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$81200.00 - $150800.00

Skills Desired

Continued Learning Dealing With Ambiguity Gmp Procedures Qa (Quality Assurance) Quality Control (Qc) Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence