QA Operations Specialist II - Quality & Compliance

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

Benefits offered by this job

RSU grants

Equity options

Medical plans and HSA/FSA

Fertility & family planning

Retirement contributions

Holidays & Paid Time Off

Job summary

Maravai LifeSciences is seeking a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, supplier management, change controls, and documentation, ensuring compliance with domestic and international standards including ISO 9001:2015.

You will lead quality events, oversee training, and drive cross-functional quality improvements while collaborating with Manufacturing, QC, R&D, and other teams to uphold quality operations.

Qualifications

• Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• 5+ years relevant experience in a life science industry.
• Knowledge of ISO 9001 standards (or ISO 13485).
• Strong verbal and written communication skills.
• Interpersonal, teamwork, and customer interfacing skills.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies.

Responsibilities

• Review and approve Quality Events (e.g., discovery events) and CAPAs to ensure investigations are completed in a timely manner.
• Provide oversight for quality operations training program and conduct quality-related training.
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness.
• Lead cross-functional teams in risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Review and approve change controls of materials, equipment, processes, and procedures including documentation.
• Maintain control of documents and records.
• Ensure compliance with ISO standards and customer requirements.
• Collaborate with Manufacturing, QC, R&D, commercial, customer service, facilities, IT, and others to improve Quality Operations.
• Lead Quality improvement projects.
• Identify quality issues and resolve discrepancies within the organization.
• Manage document change orders and update procedures and forms as required.
• Review stability protocols and packets as necessary.
• Review finished good specifications.

Skills

Quality professional

Communication skills

Problem-solving

Microsoft Office

NetSuite ERP

MasterControl

Teamwork

Self-motivation

Organizational skills

Education

Bachelor's degree in scientific discipline

Tools

NetSuite ERP

MasterControl

Job description

Maravai LifeSciences is seeking a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, supplier management, change controls, and documentation, ensuring compliance with domestic and international standards including ISO 9001:2015.

You will lead quality events, oversee training, and drive cross-functional quality improvements while collaborating with Manufacturing, QC, R&D, and other teams to uphold quality operations.