QA Operations Specialist - Shift Based

Novartis; Lavamünd; Vor Ort; EUR 78.000 - 145.000; Vollzeit

Benefits dieser Stelle

401(k) with company match

Health benefits

Paid time off

Zusammenfassung

Novartis in Carlsbad, CA is seeking a Quality Assurance professional to provide QA support across manufacturing, quality control, engineering, and supply chain operations. The role involves reviewing batch records, SOPs, CAPAs, and change controls to ensure regulatory compliance.

The position requires a life sciences degree and 3+ years in GxP bio/pharma manufacturing, plus 2+ years in QA within regulated environments. It offers a comprehensive benefits package and competitive salary.

Qualifikationen

• Bachelor's degree in Life Sciences, Chemistry, or a related relevant degree.
• Minimum 3 years in GxP bio pharmaceutical or API manufacturing operations.
• Minimum 2 years in a Quality Assurance role within a regulated environment.
• QA or QC experience in pharma environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting manufacturing compliance.
• Experience supporting regulatory inspections, continuous improvement, or operational excellence projects.
• Proven ability to collaborate effectively across functions.

Aufgaben

• Provide QA support for manufacturing, quality control, engineering and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Plans/Events, protocols and change controls.
• Perform shop floor oversight and provide compliance guidance for decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives to enhance manufacturing quality and efficiency.
• Support regulatory inspection readiness and related activities; ensure GMP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Kenntnisse

Collaboration

Data Integrity

Leadership

Operational Excellence

Ausbildung

Bachelor's degree in Life Sciences/related field

Jobbeschreibung

Job Description Summary

Location: Carlsbad, California

Shift:

This position will work a 12-hour rotating shift. Workdays will be Wednesday - Saturday with Wednesdays alternating. Shift hours are anticipated to be 8:00 am to 8:00 pm. Periodic mandatory overtime may be necessary to ensure process continuity and completion.

Job Description

Key Responsibilities

• Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.
• Perform shop floor oversight and provide compliance guidance supporting operational decision‑making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives that enhance manufacturing quality, compliance, and operational efficiency.
• Support regulatory inspection readiness, execut e inspection activities, and maintain ongoing site c G MP compliance.
• Deliver quality training and collaborate across teams to strengthen quality culture and performance.

Essential Requirements

• Bachelor's degree in Life Sciences, Chemistry, or a related relevant degree .
• Minimum 3 years of experience in G xP bio pharmaceutical or active pharmaceutical ingredient (API) manufacturing operations.
• Minimum 2 years of experience in a Quality Assurance role within a regulated environment.
• Quality Assurance or Quality Control experience in pharmaceutical environments with environmental monitoring and cleanliness zone s .
• Experience reviewing quality documentation and supporting compliance within manufacturing operations.
• Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects .
• Proven ability to collaborate effectively across functions and build strong working relationships.

The salary for this position is expected to range between $43.08 and $80.00 per hour . 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.

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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

Collaboration, Data Integrity, Leadership, Operational Excellence

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