QA Operations Lead – Quality Systems + Equity Eligible

Maravai and Kirkland & Ellis LLP; San Diego (CA); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

RSU grants

Employee stock purchase plan

Medical plans

Fertility assistance

Pet insurance

Job summary

Maravai LifeSciences is seeking a QA Operations Specialist II to join the Quality Assurance team. This role focuses on maintaining and improving the Quality Management System, reviewing deviations, NCRs, CAPAs, supplier management, and change controls, with alignment to ISO 9001:2015.

You will lead cross-functional quality initiatives, review product documentation, ensure GDP compliance, and mentor quality training, working with Manufacturing, QC, R&D, and IT to strengthen operations.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 5 years of life science QA experience.
• Knowledge of ISO 9001 standards (or ISO 13485).
• Strong verbal and written communication skills.
• Strong interpersonal, teamwork, and customer interfacing skills.
• Proficiency in Microsoft Office.
• Experience with NetSuite ERP and MasterControl is a plus.

Responsibilities

• Review and approve quality events, investigations, and CAPAs.
• Oversee quality operations training and conduct quality-related training.
• Perform quality investigations to identify root causes and verify effective CAPAs.
• Lead cross-functional risk identification and mitigation activities.
• Review and approve product documentation and change controls.
• Maintain document control and records management.
• Ensure compliance with ISO 9001 and GDP standards.

Skills

Quality Assurance

ISO 9001 Knowledge

Communication Skills

Teamwork

Problem Solving

Documentation & Records

Education

Bachelor's Degree in Life Science

Tools

NetSuite ERP

MasterControl

Job description

Maravai LifeSciences is seeking a QA Operations Specialist II to join the Quality Assurance team. This role focuses on maintaining and improving the Quality Management System, reviewing deviations, NCRs, CAPAs, supplier management, and change controls, with alignment to ISO 9001:2015.

You will lead cross-functional quality initiatives, review product documentation, ensure GDP compliance, and mentor quality training, working with Manufacturing, QC, R&D, and IT to strengthen operations.