Quality Assurance Operations Lead

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

Benefits offered by this job

RSU grants

Employee stock purchase plan

Comprehensive medical plans

HSA/FSA options

Fertility & family planning assistance

Pet insurance

Retirement contributions

Holidays & Paid Time Off

Job summary

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

You will lead cross-functional quality investigations, train operation teams, and drive continuous improvement across Manufacturing, QC, R&D, and other functions to uphold quality,

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.).
• Minimum 5 years in a life sciences quality role.
• Knowledge of ISO 9001 or ISO 13485 is required.
• Strong verbal and written communication skills.
• Experience with quality investigations and CAPAs.

Responsibilities

• Review and approve Quality Events and CAPAs to ensure timely investigations.
• Oversee quality training programs and conduct quality-related training.
• Lead quality investigations to determine root cause and effectiveness.
• Coordinate cross-functional risk identification and mitigation.
• Review and approve documentation for disposition of finished goods.

Skills

Communication skills

Interpersonal skills

Problem solving

Analytical thinking

Prioritization

Microsoft Office

Teamwork

Education

Bachelor’s degree in a scientific discipline

Tools

NetSuite ERP

MasterControl

Job description

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

You will lead cross-functional quality investigations, train operation teams, and drive continuous improvement across Manufacturing, QC, R&D, and other functions to uphold quality,