QA Operations Specialist II — Quality & Process Improvement Lead

Maravai LifeSciences; San Diego (CA); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

RSU equity

Employee stock purchase plan

Medical plans and HSA/FSA

Fertility assistance

Retirement contributions

Paid holidays

Job summary

Maravai LifeSciences is hiring a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, and supplier management, with responsibility for change controls and controlled documentation.

You will monitor quality metrics and ensure compliance with ISO 9001:2015 and related standards. The role requires a bachelor’s degree in a scientific discipline and at least 5 years in a life science setting, with strong communication and

Qualifications

• Bachelor's degree in science required.
• Minimum 5 years of experience in life science industry.
• Knowledge of ISO 9001 (or ISO 13485).
• Strong verbal and written communication skills.
• Strong interpersonal and teamwork skills.
• Strong problem-solving and analytical abilities for investigations.
• Self-motivated with ability to organize and prioritize multiple tasks.
• Proficient in Microsoft Office; NetSuite ERP and MasterControl a plus.

Responsibilities

• Review and approve Quality Events (deviations, NCRs, CAPAs, complaints) ensuring investigations are timely.
• Ensure Change Control of materials, equipment, processes, and procedures with proper documentation.
• Assist with document and record control functions as needed.
• Oversee training programs and deliver quality-related training.
• Conduct quality investigations to identify root causes and preventive actions; track effectiveness.
• Lead cross-functional risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Compile, maintain and report quality metrics including weekly/monthly/quarterly trends.
• Participate in internal and external quality audits as needed.

Skills

Quality Assurance

ISO 9001/13485

GxP Knowledge

Root Cause Analysis

Documentation Control

Audits

Cross-functional teamwork

Quality Metrics

Training Oversight

Education

Bachelor's Degree in Science

Tools

NetSuite ERP

MasterControl

Microsoft Office

Job description

Maravai LifeSciences is hiring a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, and supplier management, with responsibility for change controls and controlled documentation.

You will monitor quality metrics and ensure compliance with ISO 9001:2015 and related standards. The role requires a bachelor’s degree in a scientific discipline and at least 5 years in a life science setting, with strong communication and