QA Operations Specialist II
Maravai LifeSciences
August 11, 2026
Remote friendly (San Diego, CA)
United States
Operations
QA Operations Specialist II – Quality Assurance
Responsibilities:
- Maintain and continuously improve the Quality Management System, including review/approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation.
- Review and approve quality events (e.g., discovery events and CAPAs) to ensure timely investigations.
- Provide oversight for the quality operations training program and conduct quality training.
- Conduct quality investigations (root cause, corrections, CAPAs, effectiveness monitoring) using tools such as 5-Why, FMEA, DMAIC, cause-and-effect, and process mapping.
- Lead cross-functional risk identification/mitigation activities.
- Review/approve product documentation for disposition of finished goods and review finished-good specifications.
- Review/approve change controls for materials, equipment, processes, and procedures; manage document and record control and document change orders.
- Assure compliance with in-house/external specifications (e.g., ISO and customer requirements) and ensure GDP compliance.
- Work cross-functionally (Manufacturing, QC, R&D, commercial, etc.) to improve quality operations; lead quality improvement projects.
- Support stability protocols/packets, act as site quality representative for projects, and participate in internal/external audits; promote quality/compliance/continuous improvement.
Qualifications/Skills:
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- 5+ years relevant life sciences QA experience.
- Knowledge of ISO 9001 (or ISO 13485).
- Strong verbal/written communication; interpersonal/teamwork/customer interfacing.
- Strong analytical/problem-solving skills for investigations; self-motivated; organize/prioritize multiple tasks.
- Proficient in Microsoft Office; NetSuite ERP and MasterControl experience is a plus.
Benefits (explicitly stated): comprehensive medical plans with HSA/FSA; fertility & family planning assistance; retirement contributions; holidays & paid time off; RSU grants/employee stock purchase plan; competitive long-term incentives.
Salary range: $60,000–$70,000.
Responsibilities:
- Maintain and continuously improve the Quality Management System, including review/approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation.
- Review and approve quality events (e.g., discovery events and CAPAs) to ensure timely investigations.
- Provide oversight for the quality operations training program and conduct quality training.
- Conduct quality investigations (root cause, corrections, CAPAs, effectiveness monitoring) using tools such as 5-Why, FMEA, DMAIC, cause-and-effect, and process mapping.
- Lead cross-functional risk identification/mitigation activities.
- Review/approve product documentation for disposition of finished goods and review finished-good specifications.
- Review/approve change controls for materials, equipment, processes, and procedures; manage document and record control and document change orders.
- Assure compliance with in-house/external specifications (e.g., ISO and customer requirements) and ensure GDP compliance.
- Work cross-functionally (Manufacturing, QC, R&D, commercial, etc.) to improve quality operations; lead quality improvement projects.
- Support stability protocols/packets, act as site quality representative for projects, and participate in internal/external audits; promote quality/compliance/continuous improvement.
Qualifications/Skills:
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- 5+ years relevant life sciences QA experience.
- Knowledge of ISO 9001 (or ISO 13485).
- Strong verbal/written communication; interpersonal/teamwork/customer interfacing.
- Strong analytical/problem-solving skills for investigations; self-motivated; organize/prioritize multiple tasks.
- Proficient in Microsoft Office; NetSuite ERP and MasterControl experience is a plus.
Benefits (explicitly stated): comprehensive medical plans with HSA/FSA; fertility & family planning assistance; retirement contributions; holidays & paid time off; RSU grants/employee stock purchase plan; competitive long-term incentives.
Salary range: $60,000–$70,000.